FDA Adverse Event
Injury
Summary report: N
PASS LP
MDR report key: 6287921
·
Received January 30, 2017
Report
- Report Number
- 1000432246-2017-00002
- Event Type
- Injury
- Date Received
- January 30, 2017
- Date of Event
- May 2, 2016
- Report Date
- January 16, 2017
- Manufacturer
- MEDICREA INTERNATIONAL
- Product Code
- NKB
- PMA / PMN Number
- K141398
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADVERSE EVENT WAS IDENTIFIED AT THE FOLLOW-UP (6 MONTHS AFTER SURGERY). NO LOT NUMBER IS AVAILABLE SO NO INVESTIGATION IS POSSIBLE AT THIS STAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE COMPANY REPRESENTATIVE. DEVICE NOT EXPLANTED.
Description of Event or Problem · 1
THE FOUR CRANIAL MOST SCREWS FRACTURED WITHIN THE BONE. THE CASE HAS NOT BEEN REVISED YET, SO THE SURGEON CANNOT MAKE A TRUE ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68619 | PASS LP | PEDICLE SCREW | NKB | MEDICREA INTERNATIONAL | Ø4.5 MM X 45 MM | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |