MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-10-15 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[1690055]
The porex surgical distributor reported that the surgeon received a very "unfitting" customized implant. The distributor reported that the device could only be implanted with a "risky pressure" on the area and a lot of remodeling of the implant and therefore, was unable to use the implant.
Patient Sequence No: 1, Text Type: D, B5
[8919560]
Several attempts were made to contact the surgeon for more info on the device and the pt's condition. An investigation could not be conducted due to lack of info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00018 |
| MDR Report Key | 1880521 |
| Report Source | 08 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-09 |
| Date Mfgr Received | 2008-07-08 |
| 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 RD. |
| 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 | 2010-10-15 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2010-10-15 |