MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for CURVED PELVIC PLATE, RADIUS 108 HOLES 10 LENGTH 154.5MM FOR SCREWS ?3.5/4.5MM 425610S manufactured by Stryker Gmbh.
[124077521]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[124077522]
Fracture of a symphysis plate. Patient was in pain. Implant had to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00867 |
| MDR Report Key | 7975296 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2013-12-03 |
| Date Added to Maude | 2018-10-17 |
| 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. ANNA JUSINSKI |
| 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 | 0 |
| Brand Name | CURVED PELVIC PLATE, RADIUS 108 HOLES 10 LENGTH 154.5MM FOR SCREWS ?3.5/4.5MM |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-10-17 |
| Returned To Mfg | 2018-10-15 |
| Catalog Number | 425610S |
| Lot Number | R25761 |
| Device Expiration Date | 2018-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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. Required No Informationntervention | 2018-10-17 |