MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-09 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1474177]
The doctor reported that the pt rec'd a medpor left temporal implant on (b)(6) 2010. The doctor stated that the implant was difficult to place because of the roundness. The doctor stated that once the implant was seated over the defect and fixated; the skin flap was not able to be sutured closed w/o stressing the skin. The doctor reported that the implant had to be temporarily removed, shaved down and re-fixated. The doctor stated that the implant was shaved down enough to fit the defect and the skin flap was closed w/o issues. The doctor reported that the pt is doing well and he did not expect further issues.
Patient Sequence No: 1, Text Type: D, B5
[8703308]
Following a review of the device history record for lot number 89020-mci-352-10 f009g78h it was determined that all processes and test criteria are within the medpor customized implant finished product specification. A review of the documentation to ensure uniformity with the implant order and the doctor's request was conducted. All documentation was complete and correct with the order request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00031 |
| MDR Report Key | 1835697 |
| Report Source | 05 |
| Date Received | 2010-09-09 |
| Date of Report | 2010-09-08 |
| Date of Event | 2010-08-10 |
| Date Mfgr Received | 2010-08-10 |
| Device Manufacturer Date | 2010-07-08 |
| Date Added to Maude | 2012-03-13 |
| 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 | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-09-09 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI-35210 F009G78H |
| ID Number | 510K #K083621 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-09 |