Device brand name · Implant
Unknown_Fro_Product: medical device reports filed with FDA
192 reports name it, 2013–2026. Manufacturer given most often on reports: Stryker Leibinger Freiburg. Product code JEY.
- 192
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 7
- reports, 12 months to August 2026
- 3 in the 12 months before
- 36.5%
- classified as malfunction
- 48.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 192 reports that name the brand "Unknown_Fro_Product" (implant), received between May 2013 and August 2026; the manufacturer given most often on reports is Stryker Leibinger Freiburg. Spellings of one product vary from report to report.
7 reports arrived in the 12 months to August 2026, up 133% from 3 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 (63.5%) and malfunction (36.5%); across all plate, bone reports (product code JEY) death is recorded in 0.2% and malfunction in 48.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (23.4%), fracture (7.8%) and insufficient device problem information (7.3%). The patient problems coded most often are device embedded in tissue or plaque, pain and bone fracture(s). 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 10,487 reports carrying product code JEY. 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 | 45 | 23.4% | 35.7% |
| Fracturea broken bone | 15 | 7.8% | 8.4% |
| Insufficient device problem information | 14 | 7.3% | 5.3% |
| Loose or intermittent connection | 9 | 4.7% | 0.7% |
| Detachment of device component | 8 | 4.2% | 2.3% |
| Detachment of device or device componentpart of the device came off | 5 | 2.6% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.6% | 1.5% |
| Device slipped | 5 | 2.6% | 2.5% |
| Contamination | 4 | 2.1% | 0.1% |
| Fitting problem | 4 | 2.1% | 0.4% |
| Positioning problem | 4 | 2.1% | 0.3% |
| Device dislodged or dislocated | 3 | 1.6% | 1% |
| Connection problema connection problem | 2 | 1% | 0% |
| Difficult to removethe device was hard to remove | 2 | 1% | 0.7% |
| Failure to adhere or bond | 2 | 1% | 0.3% |
| Inadequacy of device shape and/or size | 2 | 1% | 0.7% |
| Material protrusion/extrusion | 2 | 1% | 0.2% |
| Mechanical problema mechanical problem | 2 | 1% | 0% |
| Metal shedding debris | 2 | 1% | 0.1% |
| Component falling | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 8 | 4.2% |
| Painpain, site not specified | 8 | 4.2% |
| Bone fracture(s) | 6 | 3.1% |
| Impaired healingslow healing | 6 | 3.1% |
| Foreign body in patientpart of a device left in the patient | 5 | 2.6% |
| Post operative wound infection | 4 | 2.1% |
| Rupturethe device burst | 4 | 2.1% |
| Nerve damage | 3 | 1.6% |
| Skin inflammation | 3 | 1.6% |
| Failure of implant | 2 | 1% |
| Headachehead pain | 2 | 1% |
| Injurya physical injury | 2 | 1% |
| Abscessa collection of pus | 1 | 0.5% |
| Autoimmune disorder | 1 | 0.5% |
| Bacterial infectiona bacterial infection | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown_Fro_Product | Product code JEY | All MAUDE reports |
|---|---|---|---|
| Reports | 192 | 10,487 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 63.5% | 49.8% | 36.2% |
| Classified as malfunction | 36.5% | 48.8% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 JEY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ti Matrixneuro Screw Self-Drilling 4mm | 758 | 74 | 0% |
| Cmf | 431 | 431 | 0% |
| Ti Low Profile Neuro Screw Self-Drilling 4mm | 430 | 4 | 0% |
| 2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile | 346 | 107 | 0% |
| 1 5mm Rapid Resorbable Cortex Screw 6mm | 226 | 165 | 0% |
| Level One Cmf | 546 | 32 | 0% |
| Biomet Microfixation Facial Plating System | 193 | 0 | 0% |
| 1 85mm Ti Matrix Screw Self-Tapping/6mm | 170 | 16 | 0% |
| UNK - Screws: CMF | 410 | 280 | 0% |
| Matneu Scr 1 5 Self-Drill L4 Tan 4u I/C | 180 | 41 | 0% |
| Ti Matrixneuro Screw Self-Drilling 5mm | 184 | 50 | 0% |
| Cranial-Scr PlusDrive 1.6 self-drill L4 | 165 | 8 | 0% |
| Matneu Scr 1 5 Self-Drill L4 Tan 1u I/C | 226 | 62 | 0% |
| UNK - Screws: Locking | 2,331 | 98 | 0% |
| Unk - Screws Cortex | 889 | 16 | 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 Unknown_Fro_Product reports
How many FDA reports name Unknown_Fro_Product?
192 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
injury (63.5%) and malfunction (36.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (23.4%), fracture (7.8%), insufficient device problem information (7.3%), loose or intermittent connection (4.7%) and detachment of device component (4.2%). 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 Unknown_Fro_Product 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.