MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for MEDPOR CUSTOMIZED CRANIAL-L 54440310 manufactured by Stryker Leibinger Freiburg.
[69103236]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[69103237]
It was reported that a surgeon stated that a single patient had an infection for a medpor implant, twice. Th surgeon did not believe the infection was due to the implant, but rather attributable to patient environment and noncompliance with treatment. This mdr represents the event related to the first implanted device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00046 |
| MDR Report Key | 6378255 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-03 |
| 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. JONATHAN SCHELL |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| 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 | 2017-03-03 |
| Catalog Number | 54440310 |
| Lot Number | 1601231005 |
| 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 | 2017-03-03 |