Devices › Rod, fixation, intramedullary and accessories
Device brand name · Implant
Unknown Kie Product: medical device reports filed with FDA
219 reports name it, 2013–2026. Manufacturer given most often on reports: Stryker Trauma Kiel. Product code HSB.
- 219
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 21
- reports, 12 months to August 2026
- 10 in the 12 months before
- 7.3%
- classified as malfunction
- 33% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 219 reports that name the brand "Unknown Kie Product" (implant), received between May 2013 and July 2026; the manufacturer given most often on reports is Stryker Trauma Kiel. Spellings of one product vary from report to report.
21 reports arrived in the 12 months to August 2026, up 110% from 10 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 (92.2%), malfunction (7.3%) and death (0.5%); 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 (21%), insufficient device problem information (7.8%) and fracture (6.4%). The patient problems coded most often are pain, nonunion/delayed-union bone fracture 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
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 | 46 | 21% | 21.8% |
| Insufficient device problem information | 17 | 7.8% | 2.7% |
| Fracturea broken bone | 14 | 6.4% | 8.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 13 | 5.9% | 2.7% |
| Device dislodged or dislocated | 10 | 4.6% | 1% |
| Device slipped | 9 | 4.1% | 0.7% |
| Migration or expulsion of device | 7 | 3.2% | 3% |
| Material deformation | 5 | 2.3% | 1.1% |
| Cut in material | 4 | 1.8% | 0.1% |
| Bent | 3 | 1.4% | 0.4% |
| Difficult to removethe device was hard to remove | 3 | 1.4% | 0.8% |
| Failure to adhere or bond | 3 | 1.4% | 0.4% |
| Failure to align | 3 | 1.4% | 1.9% |
| Failure to osseointegrate | 2 | 0.9% | 0.1% |
| Collapse | 1 | 0.5% | 0.1% |
| Component falling | 1 | 0.5% | 0.1% |
| Detachment of device component | 1 | 0.5% | 0.4% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% | 0.5% |
| Device difficult to setup or prepare | 1 | 0.5% | 0.2% |
| Extrusion | 1 | 0.5% | 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 |
|---|---|---|
| Painpain, site not specified | 48 | 21.9% |
| Nonunion/delayed-union bone fracture | 29 | 13.2% |
| Falla fall | 10 | 4.6% |
| Necrosisdeath of tissue | 7 | 3.2% |
| Arthralgiajoint pain | 5 | 2.3% |
| Bone fracture(s) | 4 | 1.8% |
| Foreign body in patientpart of a device left in the patient | 4 | 1.8% |
| Ambulation or postural difficulties | 3 | 1.4% |
| Arthritis | 3 | 1.4% |
| Inadequate osseointegration | 2 | 0.9% |
| Numbnessnumbness | 2 | 0.9% |
| Anemialow red blood cells | 1 | 0.5% |
| Collapse | 1 | 0.5% |
| Deformity/ disfigurement | 1 | 0.5% |
| Device embedded in tissue or plaque | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Kie Product | Product code HSB | All MAUDE reports |
|---|---|---|---|
| Reports | 219 | 37,835 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 5 | 3 | 9 |
| Classified as injury | 92.2% | 66.3% | 36.2% |
| Classified as malfunction | 7.3% | 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 Unknown Kie Product reports
How many FDA reports name Unknown Kie Product?
219 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.
What kinds of events are reported?
injury (92.2%), malfunction (7.3%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (21%), insufficient device problem information (7.8%), fracture (6.4%), device operates differently than expected (5.9%) and device dislodged or dislocated (4.6%). 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 Kie 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.