Device brand name · Implant
Unknown Product: medical device reports filed with FDA
185 reports name it, 2008–2012. Manufacturer given most often on reports: Stryker Medical. Product code FPO.
- 185
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 44.3%
- classified as malfunction
- 93.7% across the product code
- 2.7%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 185 reports that name the brand "Unknown Product" (implant), received between February 2008 and December 2012; the manufacturer given most often on reports is Stryker Medical. 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 (50.3%), malfunction (44.3%) and death (2.7%); across all stretcher, wheeled reports (product code FPO) death is recorded in 0.3% and malfunction in 93.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (17.8%), break (17.3%) and device operates differently than expected (6.5%). The patient problems coded most often are pain, tissue breakdown and injury. 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 Unknown Product was received in the five years to August 2026; the latest was received in December 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 35,248 reports carrying product code FPO. 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 |
|---|---|---|---|
| Insufficient device problem information | 33 | 17.8% | 0.4% |
| Breakthe device broke | 32 | 17.3% | 11.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 12 | 6.5% | 5.2% |
| Device slipped | 12 | 6.5% | 33.9% |
| Device dislodged or dislocated | 8 | 4.3% | 0.5% |
| Explanted | 8 | 4.3% | 0% |
| Device alarm system | 7 | 3.8% | 0% |
| Sticking | 7 | 3.8% | 8.9% |
| Replace | 6 | 3.2% | 0% |
| Mechanical problema mechanical problem | 5 | 2.7% | 5.5% |
| Collapse | 4 | 2.2% | 1.5% |
| Component falling | 4 | 2.2% | 1.1% |
| Detachment of device component | 4 | 2.2% | 1% |
| Inadequacy of device shape and/or size | 4 | 2.2% | 0% |
| Bent | 2 | 1.1% | 1.6% |
| Component missing | 2 | 1.1% | 3.3% |
| Defective devicethe device was defective | 2 | 1.1% | 0% |
| Device inoperablethe device could not be used | 2 | 1.1% | 1.9% |
| Device issuea problem with the device | 2 | 1.1% | 0.1% |
| Fracturea broken bone | 2 | 1.1% | 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 | 23 | 12.4% |
| Tissue breakdown | 12 | 6.5% |
| Injurya physical injury | 11 | 5.9% |
| Deaththe patient died; cause not stated by this term | 7 | 3.8% |
| Surgical procedure | 6 | 3.2% |
| Surgical procedure, repeated | 5 | 2.7% |
| Bone fracture(s) | 3 | 1.6% |
| Device embedded in tissue or plaque | 3 | 1.6% |
| Falla fall | 3 | 1.6% |
| Ambulation or postural difficulties | 2 | 1.1% |
| Burn(s)a burn | 2 | 1.1% |
| Discomfortdiscomfort | 2 | 1.1% |
| No patient involvement | 2 | 1.1% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 1.1% |
| Surgery, prolonged | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Product | Product code FPO | All MAUDE reports |
|---|---|---|---|
| Reports | 185 | 35,248 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 27 | 3 | 9 |
| Classified as injury | 50.3% | 3.4% | 36.2% |
| Classified as malfunction | 44.3% | 93.7% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 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 FPO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Transtar Stretcher | 5,751 | 5 | 0% |
| Sm204 M-Series W/Big Wheel | 2,796 | 7 | 0% |
| Power Pro Ambulance Cot | 3,615 | 0 | 0.4% |
| Sm104 M-Series W/5th Wheel | 985 | 0 | 0% |
| Procedural stretcher | 928 | 211 | 0% |
| Mx-Pro R-3 Ambulance Cot | 994 | 4 | 1.5% |
| Sm104 Mseries W5th Whl | 874 | 0 | 0% |
| Power Pro Ambulance Cot - Obs | 657 | 11 | 1.4% |
| Advantage Series 26 | 640 | 0 | 0% |
| Eye Surgery Stretcher | 590 | 15 | 0% |
| Sm104 Mseries W5th Whlobs3/07 | 519 | 5 | 0.4% |
| Gynnie Ob-Gyn Stretcher | 563 | 11 | 0% |
| Power Load | 463 | 8 | 1.5% |
| Prime Big Wheel Stretcher 30 | 444 | 21 | 0% |
| Advantage Series 29 | 446 | 0 | 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 Product reports
How many FDA reports name Unknown Product?
185 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 (50.3%), malfunction (44.3%) and death (2.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (17.8%), break (17.3%), device operates differently than expected (6.5%), device slipped (6.5%) and device dislodged or dislocated (4.3%). 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 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.