MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-28 for MEDPOR CUSTOMIZED CRANIAL-L 54440310 manufactured by Stryker Leibinger Freiburg.
[68597649]
The device is not available for evaluation. If additional information is received it will be reported on a supplemental report. The product was discarded by the facility at their location.
Patient Sequence No: 1, Text Type: N, H10
[68597650]
It was reported by a company representative that a patient developed a post-surgical infection after a procedure with an implant. The procedure had been completed successfully without a delay. There are no additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00039 |
| MDR Report Key | 6366474 |
| Date Received | 2017-02-28 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-02-28 |
| 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. GREGORY GOHL |
| 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 | MEDPOR CUSTOMIZED CRANIAL-L |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2017-02-28 |
| Catalog Number | 54440310 |
| Lot Number | 1609121004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-02-28 |