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 2015-08-14 for CONTOURED MANDIBULAR ANGLE - L 88037 manufactured by Stryker Orthobiologics-malvern.
[22949446]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device was discarded at the facility.
Patient Sequence No: 1, Text Type: N, H10
[22949447]
It was reported that a patient underwent a procedure in which a medpor device was implanted. After the procedure, the patient developed an infection. The sales representative was not present during the case. If additional information becomes available, it will be filed in a supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2015-00191 |
| MDR Report Key | 5003141 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-13 |
| Date Added to Maude | 2015-08-14 |
| 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. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG |
| 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 | 3 |
| Brand Name | CONTOURED MANDIBULAR ANGLE - L |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-08-14 |
| Catalog Number | 88037 |
| Lot Number | 6266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-14 |