MTS PWLD EXCLUDES FLOOR PLATE
Report
- Report Number
- 0001831750-2025-99172
- Event Type
- Malfunction
- Date Received
- July 24, 2025
- Report Date
- August 1, 2025
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- UDI-DI
- 07613327504453
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 3 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
IN ACCORDANCE WITH THE ¿FINAL GUIDANCE ON MEDICAL DEVICE REPORTING FOR MANUFACTURERS¿ ISSUED ON NOVEMBER 7, 2016, STRYKER MEDICAL WILL NO LONGER REPORT THE HAZARD OF SHARP METAL EDGES FOR OUR FASTENER LINES (PRODUCT CODE FPO), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES. WHILE NO NEW MDRS WILL BE GENERATED FOR THIS HAZARD MOVING FORWARD, ADDITIONAL SUPPLEMENTAL RECORDS MAY BE SUBMITTED FOR PAST REPORTED EVENTS IF NEW INFORMATION BECOMES AVAILABLE. SHOULD A NEW SERIOUS ADVERSE EVENT OCCUR ATTRIBUTED TO THIS HAZARD, MDR REPORTING WILL RESUME.
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
NO NEW INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1456773 | MTS PWLD EXCLUDES FLOOR PLATE | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 07613327504453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |