DENALI SPINAL SYSTEM
Report
- Report Number
- 3004774118-2017-00034
- Event Type
- Injury
- Date Received
- April 20, 2017
- Date of Event
- December 7, 2016
- Report Date
- March 21, 2017
- Manufacturer
- K2M, INC.
- Product Code
- NKB
- PMA / PMN Number
- K141873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. EVALUATION IN PROCESS.
ON 03.21.2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH SCREWS WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2016.
ON 03.21.2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH ALL HARDWARE WAS REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290378 | DENALI SPINAL SYSTEM | PEDICLE SCREW SPINAL SYSTEM | NKB | K2M, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention | THE 101-10001 LOT JKB| THE 101-73040 LOT PUY| THE 101-80028 LOT BMH| THE 801-36535M LOT JEY| THE 801-36540 LOT LAB| THE 801-36540M LOT RLW| THE 801-36545M LOT RLX |