MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-07-01 for MEDPOR CONTAIN IMPLANT UNK manufactured by Stryker Craniomaxillofacial Georgia.
[2068706]
The doctor stated that the patient had failure of a previously placed dental implant in the anterior mandible. The doctor stated that on (b)(6) 2010 the failed implant was removed and the site grafted with a layer of infuse bmp/acs, covered with a regene form block of bone, another layer of infuse, a. 35mm medpor contain implant tacked into place facially and lingually with an overlying layer of infuse over the contain implant before achieving primary soft tissue closure. The doctor observed postoperatively exposure of the medpor contain implant on the crestal portion of the bone graft. The doctor opened the site for dental implant placement, trimmed and removed a portion of the contain implant.
Patient Sequence No: 1, Text Type: D, B5
[9281218]
We are unable to determine which. 35mm contain sheet implant was used. Lot number information was not provided by the doctor to allow for review of device history records. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2011-00017 |
| MDR Report Key | 2147880 |
| Report Source | 05,07 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date Mfgr Received | 2011-06-10 |
| Date Added to Maude | 2011-07-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JEFF WILLIAMS |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 7702544400 |
| Manufacturer G1 | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR CONTAIN IMPLANT |
| Generic Name | IMPLANT |
| Product Code | NPK |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-01 |