MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for SET SCREW 7601-10001 manufactured by K2m, Inc..
[183766428]
Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[183766429]
Stryker representative reported that during patient's 6 week follow up, x-rays showed 4 yukon oct spinal system set screws at t1 and t2 had "become loose or completely disengaged" from the tulip head. Revision surgery has not been scheduled. This report represents the second of four screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2020-00033 |
| MDR Report Key | 9835736 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-07-30 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RITA KARAN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | K2M, INC. |
| Manufacturer Street | 600 HOPE PARKWAY SE |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SET SCREW |
| Generic Name | POSTERIOR CERVICAL SCREW SYSTEM |
| Product Code | NKG |
| Date Received | 2020-03-16 |
| Model Number | 7601-10001 |
| Catalog Number | 7601-10001 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | K2M, INC. |
| Manufacturer Address | 600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |