MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for PEEK CUSTOMIZED CRANIAL IMPLANT, L 78-40030 manufactured by Stryker Leibinger Freiburg.
[119533129]
The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[119533130]
It was reported that there was a discrepancy between the implant and the cranial shape, this implant was not used. An alternative implant was used. The surgery was delayed for an hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00085 |
| MDR Report Key | 7846170 |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-06 |
| Date Added to Maude | 2018-09-05 |
| 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. ZAINAB AMINI |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEEK CUSTOMIZED CRANIAL IMPLANT, L |
| Generic Name | IMPLANT |
| Product Code | GWO |
| Date Received | 2018-09-05 |
| Returned To Mfg | 2018-09-24 |
| Catalog Number | 78-40030 |
| Lot Number | 1803081006 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-05 |