MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-15 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[1690543]
The doctor stated that he planned to performed surgery on a pt to replace existing medpor malar and mandible implants with larger medpor customized bilateral malar and mandible implants. The doctor stated that the surgery started just before 9:00 am and he had removed the existing malar implants by 1:00 pm. The doctor stated that he lightly burred the surface before placing the customized malar implants through the incision. The doctor stated that once the implants were in position, the implants rocked from side to side. The doctor stated that he removed some material from the anterior surface of the implant and fixated with screws. The doctor stated that this took an additional 30 mins and he chose to close and not address the mandibular implants in the procedure. The doctor stated that the pt was not satisfied with the symmetry after the surgery and wanted the medpor implants modified. The doctor stated that was concerned with the implant current position not sitting securely on the pt's bone could cause an infection. The doctor stated that the pt was adamant about having augmentation by medpor and not soft tissue; therefore, the doctor stated that a medpor sheet could be carved to be placed with the customized malar to ensure no movement. The doctor stated that the pt is in good health but unhappy with the surgical outcome.
Patient Sequence No: 1, Text Type: D, B5
[8919561]
Catalog number: 89022. Lot number: c009m128h; (b)(4), c011m128h, c012m128h.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00017 |
| MDR Report Key | 1880523 |
| Report Source | 05 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-11 |
| Date of Event | 2008-05-20 |
| Date Mfgr Received | 2008-07-09 |
| Device Manufacturer Date | 2007-11-01 |
| 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 IMPLANT |
| Product Code | JOF |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | 89021-MCI-166-07 C008M128H |
| ID Number | 510K #K083621 |
| Device Expiration Date | 2017-11-01 |
| 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 |