MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-15 for COMBINED SUBMALAR SHELL-SMALL CSM-S manufactured by Implantech Associates, Inc..
[1327575]
Complainant reported that left side malar implant was explanted 41 days after initial placement, due to displacement/migration. The device was replaced approx 5 months after the explant surgery.
Patient Sequence No: 1, Text Type: D, B5
[8403433]
Method: reviewed device history records, product labeling and complaint records. Results: device history record review found no assignable cause for reported event. A review of complaint records indicates there have been no other complaints on this lot. Product labeling warns that "displacement or shifting of the implant can occur from too large a pocket. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2009-00005 |
| MDR Report Key | 1509425 |
| Report Source | 05 |
| Date Received | 2009-10-15 |
| Date of Report | 2009-10-15 |
| Date of Event | 2009-04-15 |
| Date Mfgr Received | 2009-09-15 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-10-20 |
| 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 | 8003399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBINED SUBMALAR SHELL-SMALL |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2009-10-15 |
| Model Number | NA |
| Catalog Number | CSM-S |
| Lot Number | 823880 |
| ID Number | NA |
| Device Expiration Date | 2012-05-01 |
| 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 | 2009-10-15 |