FDA Adverse Event
Malfunction
Summary report: N
MANDIBULAR FRACTURE PLATE, 14-HOLES
MDR report key: 2240943
·
Received August 17, 2011
Report
- Report Number
- 8010177-2011-00245
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- May 17, 2011
- Report Date
- July 26, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K014263
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED AND THUS DEEPER INVESTIGATIONS COULD NOT BE PERFORMED. THE ACTUAL ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE OF THE FAILURE CAN BE ATTRIBUTED TO DYNAMIC OVERLOAD ON THE PLATE. BASED ON STATISTICAL EVALS, INDICATIONS FOR ANY DEVICE RELATED ISSUES WERE NOT FOUND.
Description of Event or Problem · 1
DOCTOR PUT IN A 14 HOLE FRACTURE PLATE ON (B)(6) AND IT SNAPPED IN PATIENTS MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANDIBULAR FRACTURE PLATE, 14-HOLES | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |