MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-26 for TERINO MALAR SHELL IMPLANT- LARGE TMS-L5 manufactured by Implantech Associates, Inc..
[1105196]
A report was received that a pt who had been implanted with malar implants developed an infection on the left side approximately 2 months post operatively. Pt was treated with oral keflex. Symptoms partially resolved, however, the left side device was explanted 14 weeks post operatively. No culture was obtained, and no specific organism was identified.
Patient Sequence No: 1, Text Type: D, B5
[8435557]
Method: reviewed device history records, sterilization records, and product labeling. Results: device history record review revealed no assignable cause for the reported event. The sterilization process was within specified parameters, and there have been no other reports of infection involving this sterile lot. Product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2009-00004 |
| MDR Report Key | 1408755 |
| Report Source | 05 |
| Date Received | 2009-06-26 |
| Date of Report | 2009-06-26 |
| Date of Event | 2009-05-28 |
| Date Mfgr Received | 2009-05-29 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-07-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE MEADE |
| Manufacturer Street | 6025 NICOLLE ST, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERINO MALAR SHELL IMPLANT- LARGE |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2009-06-26 |
| Model Number | NA |
| Catalog Number | TMS-L5 |
| Lot Number | 827849 |
| ID Number | NA |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-26 |