MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2014-03-18 for TERINO MALAR SHELL IMPLANT TMS-S4 manufactured by Implantech Associates, Inc..
[21882507]
Complainant reported patient was implanted with bilateral malar implants via an intraoral approach. Approximately two months post-op, patient presented with pain and swelling on her right side. The patient was given antibiotics for one week, however symptoms did not resolve. The right side implant was explanted approximately 10 weeks post-op. The left side was not affected and the left side implant was not explanted. During the explant surgery, pus was found surrounding the right side implant. No culture was taken, and no specific organism has been identified. A few days after removal of the right side device, the patient was seen and exhibited no pain and reduced swelling.
Patient Sequence No: 1, Text Type: D, B5
[22147943]
Method: reviewed device history records, sterilization records, and product labeling. Results: device history records review revealed no assignable cause for the reported event. The sterilization process with within specified parameters, and there have been no other reports of infection involving this sterile lot. (total of (b)(4) products). Product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2014-00002 |
| MDR Report Key | 3708830 |
| Report Source | 01,05,08 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-01-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-03-31 |
| 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 | 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 |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2014-03-18 |
| Model Number | NA |
| Catalog Number | TMS-S4 |
| Lot Number | 842875 |
| ID Number | NA |
| Device Expiration Date | 2016-12-01 |
| 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 | 2014-03-18 |