MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-15 for STRAIGHT ACETABULAR PLATE HOLES 18 LENGTH 214.5MM FOR SCREWS ?3.5/4.5MM 425768 manufactured by Stryker Gmbh.
[111295853]
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
[111295854]
Orif of fracture of the pelvis ring with use of stryker plates (matta, 18 holes flexplate). The received photo confirms the plate to be broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00470 |
| MDR Report Key | 7607269 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-15 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2015-05-09 |
| Date Added to Maude | 2018-06-15 |
| 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 | STRAIGHT ACETABULAR PLATE HOLES 18 LENGTH 214.5MM FOR SCREWS ?3.5/4.5MM |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-06-15 |
| Returned To Mfg | 2018-07-20 |
| Catalog Number | 425768 |
| Lot Number | J14753 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2018-06-15 |