FDA Adverse Event
Malfunction
Summary report: N
EVEREST SPINAL SYSTEM
MDR report key: 7883023
·
Received September 17, 2018
Report
- Report Number
- 3004774118-2018-00142
- Event Type
- Malfunction
- Date Received
- September 17, 2018
- Date of Event
- August 23, 2018
- Report Date
- August 23, 2018
- Manufacturer
- K2M. INC
- Product Code
- NKB
- PMA / PMN Number
- K151727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION, K2M, INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.
Description of Event or Problem · 1
ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SCREW BROKE APPROXIMATELY 4-6 MONTH POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724182 | EVEREST SPINAL SYSTEM | PEDICLE SCREW SPINAL SYSTEM | NKB | K2M. INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |