MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-24 for NILE ALTERNATIVE FIXATION SYSTEM SYSTEM 5401-90030 manufactured by K2m. Inc.
[142926685]
A comprehensive investigation was immediately initiated on receipt of the complaint. The subject product has not been returned for evaluation yet. Investigation is still in process. When investigation is complete, k2m inc. Will file a supplemental report indicating the findings.
Patient Sequence No: 1, Text Type: N, H10
[142926686]
On (b)(6) 2019 it was reported to k2m, inc that during final tightening, the tip of a driver shaft broke intra-operatively. The tip of the driver shaft remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004774118-2019-00041 |
| MDR Report Key | 8544040 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-24 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2019-04-24 |
| 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 | MRS. EVA JAMES |
| Manufacturer Street | 600 HOPE PARKWAY SE |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal | 20175 |
| Manufacturer Phone | 5719192080 |
| Manufacturer G1 | K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION |
| 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 | NILE ALTERNATIVE FIXATION SYSTEM SYSTEM |
| Generic Name | BONE FIXATION CERCLAGE, SUBLAMINAR |
| Product Code | OWI |
| Date Received | 2019-04-24 |
| Catalog Number | 5401-90030 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-24 |