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 |