FDA Adverse Event
Malfunction
Summary report: N
M PROFILE PLATE, T-SHAPE, 90 DEGREES NARROW, 6 HOL
MDR report key: 2852173
·
Received November 12, 2012
Report
- Report Number
- 8010177-2012-00252
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER LEIBINGER GMBH & CO. KG
- Product Code
- HRS
- PMA / PMN Number
- K062498
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATE WAS BROKEN DURING SURGERY. THE PLATE WAS IMPLANTED AND BROKE AFTER THE IMPLANTATION AND HENCE IT WAS EXPLANTED. ANOTHER PLATE WAS AVAILABLE AND WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M PROFILE PLATE, T-SHAPE, 90 DEGREES NARROW, 6 HOL | IMPLANT | HRS | STRYKER LEIBINGER GMBH & CO. KG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |