MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL 78-10040 manufactured by Stryker Leibinger Freiburg.
[122304099]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[122304100]
It was reported that the custom implant did not fit the way the surgeon wanted. Per the surgeon, "it was too flat". The procedure was completed by the surgeon burring down the posterior portion of the cci to reduce the gap and to create a less palpable shape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00092 |
| MDR Report Key | 7919658 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-09-28 |
| 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 KIT, XL |
| Generic Name | IMPLANT |
| Product Code | GWO |
| Date Received | 2018-09-28 |
| Catalog Number | 78-10040 |
| Lot Number | 1803201008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-28 |