MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-24 for TERINO MALAR SHELL, LARGE TMS-L5 manufactured by Implantech Associates, Inc..
[16397057]
Physician reported that patient noticed that left implant appeared different from right implant. After cat scan, physician also felt that implants appeared different. Almost 6 months after implantation, the physician explanted both devices. Upon explantation, the left side device was found to be eroding into sinus.
Patient Sequence No: 1, Text Type: D, B5
[16648954]
Method: reviewed device history records. Results: device history record review revealed no assignable cause for the reported events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2007-00004 |
| MDR Report Key | 903101 |
| Report Source | 05 |
| Date Received | 2007-08-24 |
| Date of Report | 2007-08-24 |
| Date of Event | 2007-08-13 |
| Date Mfgr Received | 2007-07-30 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-08-30 |
| 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 | STEPHEN 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, LARGE |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2007-08-24 |
| Model Number | NA |
| Catalog Number | TMS-L5 |
| Lot Number | 820997 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 879259 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-24 |