Devices › Rod, fixation, intramedullary and accessories
Device brand name · Rod fixation intramedullary and accessories
Precice Intramedullary Limb Lengthening Rod: medical device reports filed with FDA
177 reports name it, 2012–2019. Manufacturer given most often on reports: Nuvasive Specialized Orthopedics. Product code HSB.
- 177
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 11.9%
- classified as malfunction
- 33% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 177 reports that name the brand "Precice Intramedullary Limb Lengthening Rod" (rod fixation intramedullary and accessories), received between May 2012 and August 2019; the manufacturer given most often on reports is Nuvasive Specialized Orthopedics. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 injury (88.1%) and malfunction (11.9%); 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 device operates differently than expected (27.7%), break (26%) and defective device (5.6%). The patient problems coded most often are failure of implant, therapeutic response, decreased and fall. 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
No report naming Precice Intramedullary Limb Lengthening Rod was received in the five years to August 2026; the latest was received in August 2019.
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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 49 | 27.7% | 2.7% |
| Breakthe device broke | 46 | 26% | 21.8% |
| Defective devicethe device was defective | 10 | 5.6% | 0.4% |
| Fracturea broken bone | 9 | 5.1% | 8.1% |
| Material separation | 8 | 4.5% | 0.2% |
| Inadequacy of device shape and/or size | 7 | 4% | 0.3% |
| Insufficient device problem information | 6 | 3.4% | 2.7% |
| Mechanical problema mechanical problem | 6 | 3.4% | 0.9% |
| Device dislodged or dislocated | 4 | 2.3% | 1% |
| Mechanics altered | 4 | 2.3% | 0.1% |
| Material integrity problema problem with the device material | 3 | 1.7% | 0.3% |
| Bent | 2 | 1.1% | 0.4% |
| Crackthe device cracked | 2 | 1.1% | 0.4% |
| Detachment of device component | 2 | 1.1% | 0.4% |
| Device inoperablethe device could not be used | 2 | 1.1% | 0.1% |
| Disconnection | 2 | 1.1% | 0% |
| Human-device interface problem | 2 | 1.1% | 0.1% |
| Improper or incorrect procedure or method | 2 | 1.1% | 0.6% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 1.1% | 0.1% |
| Sticking | 2 | 1.1% | 0.5% |
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 | 10 | 5.6% |
| Therapeutic response, decreased | 5 | 2.8% |
| Falla fall | 3 | 1.7% |
| Injurya physical injury | 2 | 1.1% |
| Painpain, site not specified | 2 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.6% |
| Fever | 1 | 0.6% |
| Impaired healingslow healing | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Precice Intramedullary Limb Lengthening Rod | Product code HSB | All MAUDE reports |
|---|---|---|---|
| Reports | 177 | 37,835 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 88.1% | 66.3% | 36.2% |
| Classified as malfunction | 11.9% | 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 Intramedullary Limb Lengthening Rod reports
How many FDA reports name Precice Intramedullary Limb Lengthening Rod?
177 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?
injury (88.1%) and malfunction (11.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (27.7%), break (26%), defective device (5.6%), fracture (5.1%) and material separation (4.5%). 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 Intramedullary Limb Lengthening Rod 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.