MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-18 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[765236]
The doctor stated that a patient received a medpor left orbital rim/zygomatic onlay implant in 2007. The doctor stated that while the implant fit great, the implant area became infected within 3 to 4 four days after the surgery and he removed it. The doctor stated that he has never had a problem with an orbital implant and will reaccess how he places implants intraorally.
Patient Sequence No: 1, Text Type: D, B5
[8087577]
The device history records were reviewed and all processes and test criteria have been verified as complying with the medpor implant specification. A copy of the current instructions for use and labeling with cautions highlighted is enclosed addl. Lot number c012k117h.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00023 |
| MDR Report Key | 967348 |
| Report Source | 05 |
| Date Received | 2007-12-18 |
| Date of Report | 2007-12-17 |
| Date Mfgr Received | 2007-11-30 |
| Date Added to Maude | 2008-05-22 |
| 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 | FACIAL RECONSTRUCTION |
| Product Code | HPZ |
| Date Received | 2007-12-18 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI28607 |
| ID Number | NA |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 974069 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-12-18 |