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 81068 manufactured by Stryker Craniomaxillofacial Georgia.
[18841867]
The doctor reported that the patient received a (b)(4) contain sheet implant in (b)(6) 2010 to graft the lower right mandible with infuse bmp-2. The doctor stated that the contain implant was tacked in place with titanium tacks. The doctor stated that in (b)(6) 2011, he observed approximately 3mm tissue fenestration on the lingual aspect of the bone graft site while waiting for the bone graft to consolidate. The doctor stated the he observed swelling on the facial side of the graft site. The patient was started on antibiotics and the swelling reduced. The doctor stated that there is adequate bone to place the dental implants but the bone graft was not as large as he expected.
Patient Sequence No: 1, Text Type: D, B5
[19037347]
The device history records were reviewed and all processes and test criteria were within the (b)(4) implant specification. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2011-00016 |
| MDR Report Key | 2147894 |
| Report Source | 05,07 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 2010-03-31 |
| 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 | 81068 |
| Lot Number | F085C03 |
| 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 |