MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-09 for PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL 78-50040 manufactured by Stryker Leibinger Freiburg.
[123107546]
Device is not available for evaluation. If additional information is received, it will be reported on a supplemental report. Device unable to be returned.
Patient Sequence No: 1, Text Type: N, H10
[123107547]
It was reported that an implant was removed due to infection. Another exact implant was manufactured to replace the first one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00098 |
| MDR Report Key | 7947235 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KELLI DYKSTRA |
| 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 | 3 |
| Brand Name | PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL |
| Generic Name | IMPLANT |
| Product Code | GWO |
| Date Received | 2018-10-09 |
| Catalog Number | 78-50040 |
| Lot Number | 1710171012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Brand Name | PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL |
| Generic Name | IMPLANT |
| Product Code | GWO |
| Date Received | 2018-10-09 |
| Catalog Number | 78-50040 |
| Lot Number | 1710171012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2018-10-09 |