MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-10-15 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1669696]
The doctor reported to a porex surgical distributor that the pt received medpor customized left parietal cranial implant. The doctor stated that the customized left parietal cranial implant was about 2 cm too large. The doctor stated that he had to adjust the fitting with forceps and bone punches and it cost him an additional hour of surgery time. The doctor stated that the main objective of filling the defect was accomplished.
Patient Sequence No: 1, Text Type: D, B5
[8891195]
Following a review of the device history record for lot number 89020-mci-570-09 f005b13h, 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 | 1057129-2010-00028 |
| MDR Report Key | 1880524 |
| Report Source | 05,08 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-10 |
| Date Mfgr Received | 2010-03-01 |
| Device Manufacturer Date | 2010-02-01 |
| 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 IMPLANTS |
| Product Code | JOF |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI-570-09F005B13H |
| 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. Hospitalization; 2. Other | 2010-10-15 |