MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-02 for MANDIBLE ANGLE - RIGHT - 47MM 7536 manufactured by Stryker Orthobiologics-malvern.
[81605726]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Discarded at facility.
Patient Sequence No: 1, Text Type: N, H10
[81605727]
It was reported that the patient had the device implanted in (b)(6) 2017 and then developed local inflammation and pain in the left side. The patient was also dissatisfied with the asymmetrical end result. Because of these reasons, the implant was removed in (b)(6) 2017. No dislocation of implants or loosening of screws were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00192 |
| MDR Report Key | 6760248 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-08-02 |
| 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 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 | 3 |
| Brand Name | MANDIBLE ANGLE - RIGHT - 47MM |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2017-08-02 |
| Catalog Number | 7536 |
| Lot Number | A1508063 |
| 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. Required No Informationntervention | 2017-08-02 |