MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-06-25 for MEDPOR IMPLANT 9513 manufactured by Porex Surgical.
[632162]
The surgeon stated that he had a patient who received left and right medpor malar implants about 16 months earlier in a procedure performed by another surgeon. The malar implants had migrated and the surgeon inquired about the removal procedure for medpor implants. He was referred to a surgeon who serves as a consultant for the company and has experience with medpor. Porex's consultant reported to the company that the reporting surgeon had tried to remove the implants but they would not come out. (see highlighted section of medpor instruction for use enclosed).
Patient Sequence No: 1, Text Type: D, B5
[7970842]
We were provided item numbers but we did not receive lot number information. We have attempted to contact the doctor concerning patient condition after surgery and have been unable to obtain additional information. We were contacted by the patient concerning the surgery. The patient stated that the original surgeon placed two medpor malar implants after removing silicone implants. The doctor had difficulty placing the malar implants due to a great deal of scar tissue from years of silicone implants. According to the patient, the doctor secured both implants with screws. Shortly after surgery the patient noticed a sharp protruding point on the left cheek. One to two weeks after surgery, the patient believed that one of the implants had rotated and was resting on the facial nerve. Five months after surgery, the doctor trimmed the protruding point off the left malar implant by rasping it down. The patient stated that the doctor checked the right implant to see if the implant was rotated and indicated that the implant was located where it was originally placed. The patient stated that she consulted another doctor twelve months after the surgery to have the implant removed. The doctor told the patient that he could not remove the implants because they were hard as a rock and would need to be chiseled out. The patient went to the doctor who contacted us for removal information. The patient stated the doctor attempted to remove the malar implants but could not and instructed her to go to the clinic for removal. A copy of the current instructions for use with contraindications listed is enclosed. (please see additional scanned pages).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00008 |
| MDR Report Key | 871990 |
| Report Source | 04,05 |
| Date Received | 2007-06-25 |
| Date of Report | 2007-06-20 |
| Date Mfgr Received | 2007-04-24 |
| Date Added to Maude | 2007-07-02 |
| 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 | FACIAL RECONSTRUCTION |
| Product Code | LZK |
| Date Received | 2007-06-25 |
| Model Number | NA |
| Catalog Number | 9513 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 853600 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-25 |