MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-09 for CONFORM TERINO MALAR SHELL (R) CTMS-XL4 manufactured by Implantech Associates.
[16179947]
Complainant reported that patient complained of pain on the left side more than 6 months post-implantation with bilateral malar implants. Over an extended period of time, patient received multiple d and c procedures with drainage of pus, as well as multiple courses of augmentin (po), amoxicillin (po) and medrol dose packs. On (b)(6) 2013, a biopsy was taken and staphylococcus aureus was identified. Eventually, patient and physician agreed upon removal. Left side device was explanted approximately 25 months post-operatively. Symptoms appear to have resolved, and the prognosis is to re-implant the left side with a new device in the near future.
Patient Sequence No: 1, Text Type: D, B5
[16344405]
Patient: infection bacterial. Device: no known device problem. Method: reviewed device history records, sterilization records, environmental monitoring records, and product labeling. Results: device history records review found no assignable cause for the reported events. The sterilization process was within specified parameters, and there have been no other infection-related complaint reports associated with this sterile lot of (b)(4) devices. Product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2015-00001 |
| MDR Report Key | 4410111 |
| Report Source | 05 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-08-08 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2015-01-13 |
| 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 | CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Street | 6025 NICOLLE ST., SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORM TERINO MALAR SHELL (R) |
| Generic Name | MALAR IMPLANTS |
| Product Code | LZK |
| Date Received | 2015-01-09 |
| Model Number | NA |
| Catalog Number | CTMS-XL4 |
| Lot Number | 839493 |
| ID Number | NA |
| Device Expiration Date | 2016-04-01 |
| 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 |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-09 |