MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for ANCHORAGE SCREW UNK_SEL manufactured by Stryker Gmbh.
[39330858]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[39330859]
It was reported by the distribution manager that the screw went through the plate during surgery so another plate and screw was used to complete the surgery. No complications or delay.
Patient Sequence No: 1, Text Type: D, B5
[48011337]
The reported incident that an unknown anchorage screw was alleged of issue s-41 (poor fixation) could be confirmed since this is a known design issue. The root cause of this positioning issue has been identified as a design issue. The nc 565281 has been opened for recurring issue. The threshold defined in the risk management file was not exceeded. Design improvement actions were identified in capa (b)(4). Design improvements consist in changing tolerances of the screw head in order to strengthen the connectivity between plate and screws. A review of the device history was not possible because the lot number was not communicated. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. If the device is returned or if any additional information is provided, the investigation will be reassessed. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[48011338]
It was reported by the distribution manager that the screw went through the plate during surgery so another plate and screw was used to complete the surgery. No complications or delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2016-00081 |
| MDR Report Key | 5458363 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-01-27 |
| Date of Event | 2016-01-27 |
| Date Mfgr Received | 2016-05-25 |
| Date Added to Maude | 2016-02-24 |
| 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 | MR. ROSE HAAS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHORAGE SCREW |
| Generic Name | IMPLANT |
| Product Code | OAT |
| Date Received | 2016-02-24 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-24 |