Devices › Rod, fixation, intramedullary and accessories
Device brand name · Rod fixation intramedullary and accessories
Precice System: medical device reports filed with FDA
162 reports name it, 2020–2024. Manufacturer given most often on reports: Nuvasive Specialized Orthopedics. Product code HSB.
- 162
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 4 in the 12 months before
- 58.6%
- classified as malfunction
- 33% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
162 medical device reports received by FDA name the brand "Precice System" (rod fixation intramedullary and accessories); the manufacturer given most often on reports is Nuvasive Specialized Orthopedics; received from July 2020 to December 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 4 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (58.6%) and injury (41.4%); across all rod, fixation, intramedullary and accessories reports (product code HSB) death is recorded in 0.3% and malfunction in 33%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (24.1%), failure to advance (22.8%) and mechanical problem (17.9%). The patient problems coded most often are failure of implant, appropriate clinical signs, symptoms and conditions term/code not available and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 37,835 reports carrying product code HSB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 39 | 24.1% | 21.8% |
| Failure to advance | 37 | 22.8% | 0.7% |
| Mechanical problema mechanical problem | 29 | 17.9% | 0.9% |
| Defective devicethe device was defective | 10 | 6.2% | 0.4% |
| Material twisted/bent | 10 | 6.2% | 1.3% |
| Detachment of device or device componentpart of the device came off | 8 | 4.9% | 0.5% |
| Unintended system motionthe device moved when it should not have | 7 | 4.3% | 0% |
| Fracturea broken bone | 6 | 3.7% | 8.1% |
| Migrationthe device moved from where it was placed | 5 | 3.1% | 6.1% |
| Collapse | 3 | 1.9% | 0.1% |
| Crackthe device cracked | 2 | 1.2% | 0.4% |
| Corrodedthe device corroded | 1 | 0.6% | 0.3% |
| Device damaged by another device | 1 | 0.6% | 0.2% |
| Difficult to advance | 1 | 0.6% | 0.4% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.6% | 0% |
| Insufficient device problem information | 1 | 0.6% | 2.7% |
| Loosening of implant not related to bone-ingrowth | 1 | 0.6% | 0.2% |
| Material deformation | 1 | 0.6% | 1.1% |
| Mechanical jam | 1 | 0.6% | 1.1% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.6% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Failure of implant | 100 | 61.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 5.6% |
| Painpain, site not specified | 9 | 5.6% |
| Bone fracture(s) | 6 | 3.7% |
| Impaired healingslow healing | 5 | 3.1% |
| Implant pain | 5 | 3.1% |
| Metal related pathology | 4 | 2.5% |
| Nonunion/delayed-union bone fracture | 4 | 2.5% |
| Discomfortdiscomfort | 2 | 1.2% |
| Nerve damage | 2 | 1.2% |
| Wound dehiscencea wound reopened | 2 | 1.2% |
| Deformity/ disfigurement | 1 | 0.6% |
| Extraskeletal ossification | 1 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Precice System | Product code HSB | All MAUDE reports |
|---|---|---|---|
| Reports | 162 | 37,835 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 41.4% | 66.3% | 36.2% |
| Classified as malfunction | 58.6% | 33% | 62.3% |
| Filed by the manufacturer | 100% | 98.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code HSB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sign Im Nail | 2,301 | 226 | 0% |
| UNK - Nails: TFNA | 412 | 24 | 0% |
| Trochanteric Nail Kit Ti Gamma3 11x180mm X 125 | 366 | 0 | 0.3% |
| Unknown T2 Scn | 355 | 0 | 0% |
| SIGN Fin NAIL | 335 | 50 | 0% |
| UNK - Nail Head Elements: TFNA Helical Blade | 270 | 13 | 0% |
| Unk - Nail Head Elements Pfna Blade | 260 | 1 | 0% |
| Radiolucent Insertion Handle Frn | 256 | 14 | 0% |
| Helical Blade/Screw Coupling Screw | 226 | 41 | 0% |
| Precice Stryde System | 226 | 0 | 0% |
| Lag Screw Driver | 223 | 14 | 0% |
| Unknown T2 Tibia Nail | 223 | 0 | 0% |
| Cannulated Connecting Screw | 206 | 27 | 0% |
| Target Device Gamma3 300x160mm | 239 | 1 | 0% |
| Unknown T2 Alpha Tibia Nail | 199 | 175 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Precice System reports
How many FDA reports name Precice System?
162 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (58.6%) and injury (41.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (24.1%), failure to advance (22.8%), mechanical problem (17.9%), defective device (6.2%) and material twisted/bent (6.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Precice System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.