Devices › Nail, fixation, bone
Device brand name · Internal fixation
Trigen: medical device reports filed with FDA
228 reports name it, 2001–2016. Manufacturer given most often on reports: Smith & Nephew Orthopaedic Div. Product code JDS.
- 228
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 5.3%
- classified as malfunction
- 32% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
228 medical device reports received by FDA name the brand "Trigen" (internal fixation); the manufacturer given most often on reports is Smith & Nephew Orthopaedic Div; received from August 2001 to November 2016. 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, 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 (93.4%) and malfunction (5.3%); across all nail, fixation, bone reports (product code JDS) death is recorded in 0.2% and malfunction in 32%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (28.5%), explanted (27.6%) and fracture (12.3%). The patient problems coded most often are surgery, prolonged, hospitalization required and surgical procedure. 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 Trigen was received in the five years to August 2026; the latest was received in November 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 7,240 reports carrying product code JDS. 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 | 65 | 28.5% | 20.9% |
| Explanted | 63 | 27.6% | 6% |
| Fracturea broken bone | 28 | 12.3% | 6.3% |
| Replace | 22 | 9.6% | 2.8% |
| Difficult to removethe device was hard to remove | 16 | 7% | 0.9% |
| Insufficient device problem information | 15 | 6.6% | 5.7% |
| Difficult to insertthe device was hard to insert | 12 | 5.3% | 0.6% |
| Component(s), broken | 11 | 4.8% | 0.6% |
| Device remains implanted | 10 | 4.4% | 0.7% |
| Device, or device fragments remain in patient | 9 | 3.9% | 0.3% |
| Displacement | 4 | 1.8% | 0.1% |
| Migration or expulsion of device | 4 | 1.8% | 2.3% |
| Bent | 3 | 1.3% | 0.7% |
| Connection problema connection problem | 3 | 1.3% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1.3% | 1.9% |
| Component falling | 2 | 0.9% | 0% |
| Detachment of device component | 2 | 0.9% | 0.3% |
| Disengaged | 2 | 0.9% | 0% |
| Failure to align | 2 | 0.9% | 1.1% |
| Fitting problem | 2 | 0.9% | 0.8% |
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 |
|---|---|---|
| Surgery, prolonged | 47 | 20.6% |
| Hospitalization required | 38 | 16.7% |
| Surgical procedure | 36 | 15.8% |
| Surgical procedure, repeated | 31 | 13.6% |
| Nonresorbable materials, unretrieved in body | 9 | 3.9% |
| Painpain, site not specified | 5 | 2.2% |
| Surgical procedure, additional | 5 | 2.2% |
| Surgical procedure, delayed | 4 | 1.8% |
| Bone fracture(s) | 2 | 0.9% |
| Falla fall | 2 | 0.9% |
| Nonunion/delayed-union bone fracture | 2 | 0.9% |
| Surgical procedure aborted/stopped | 2 | 0.9% |
| Therapy/non-surgical treatment, additional | 2 | 0.9% |
| Arthralgiajoint pain | 1 | 0.4% |
| Blood loss | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Trigen | Product code JDS | All MAUDE reports |
|---|---|---|---|
| Reports | 228 | 7,240 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 93.4% | 67.4% | 36.2% |
| Classified as malfunction | 5.3% | 32% | 62.3% |
| Filed by the manufacturer | 95.6% | 98.3% | 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 JDS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Aiming Arm/ Radiolucent | 465 | 82 | 0% |
| Insertion Handle/ Radiolucent Long | 240 | 79 | 0% |
| Trauma Implant | 264 | 0 | 0.4% |
| Unkn TRIGEN INTERTAN Intertroch Antegr Nail | 169 | 3 | 0% |
| UNK - Guide/Compression/K-Wires | 213 | 14 | 0% |
| Unk - Nails | 180 | 12 | 0% |
| Unk - Nail Head Elements Fns Antirotation | 182 | 6 | 0% |
| UNK - Nails: TFNA | 412 | 24 | 0% |
| UNK - Nail Head Elements: TFNA Helical Blade | 270 | 13 | 0% |
| Unkn Taylor Spatial Frame Exfix Dev | 175 | 0 | 0% |
| Unk - Nail Head Elements Fns Bolt | 185 | 12 | 0% |
| Unknown T2 Tibia Nail | 223 | 0 | 0% |
| Unknown T2 Alpha Tibia Nail | 199 | 175 | 0% |
| 130 Deg Aiming Arm F/Trochanteric Fixation Nails | 215 | 0 | 0% |
| UNK - Screws: Nail Distal Locking | 444 | 12 | 0.2% |
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 Trigen reports
How many FDA reports name Trigen?
228 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 (93.4%) and malfunction (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (28.5%), explanted (27.6%), fracture (12.3%), replace (9.6%) and difficult to remove (7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Trigen 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.