MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2015-08-13 for CONTOURED MANDIBULAR ANGLE - L 88037 manufactured by Stryker Orthobiologics - Malvern.
[23243414]
Device is not available for eval. If add'l info is received, it will be reported on a supplemental report. Pr # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23243415]
It was reported that a pt underwent a procedure in which a medpor device was implanted. After the procedure, the pt developed an infection. The sales rep was not present during the case. If add'l info becomes available, it will be filed in a supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010177-2015-00191 |
| MDR Report Key | 5006601 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2015-08-13 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-13 |
| Date Added to Maude | 2015-08-17 |
| 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 | KELLI DYKSTRA |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG, DE D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 6145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PKWY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONTOURED MANDIBULAR ANGLE - L |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-08-13 |
| Catalog Number | 88037 |
| Lot Number | 6266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS - MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PKWY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |