MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for CONFORM BINDER SUBMALAR (R) IMPLANT N/A CBSM-XL manufactured by Implantech Associates, Inc..
[58602580]
Evaluation summary: method: reviewed device history records, sterilization records, environmental monitoring records, and product labeling. Actual device was not evaluated. Results: the reviews above found no assignable cause for the reported event. The sterilization process was within specified parameter, and there have been no other reports of infection involving this sterile lot. ((b)(4)) product labeling addresses the possibility of infection. Conclusion: the possibility of infections is a known, inherent risk associated with implant surgery. Note: initial report was sent via mail 09/07/201616 and is now being resent 10/25/2016.
Patient Sequence No: 1, Text Type: N, H10
[58602581]
Complainant reported that patient's left side malar implant was explanted approximately 5 months post-operatively due to infection. Approximately 1 month post-operatively, the patient reported swelling continued for a few months even with the use of antibiotics to control the infection and pain. Testing performed after removal of the device found "heavy growth (b)(6). " at the time of this report, the infection had resolved. Device was implanted at (b)(6) building operating room and was explanted at the physician's office. Patient had ear keloid excision on the same date as the malar implant placement. Patient has prior history of (b)(6). Although (b)(6) infections are often associated with hospitals and surgery centers, and are more likely to occur in persons with compromised immune systems, implantech has elected to report this event as the reporting physician has not absolved the device from causing or contributing to the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2016-00001 |
| MDR Report Key | 6062528 |
| Date Received | 2016-10-27 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-02-11 |
| Date Mfgr Received | 2016-08-09 |
| Device Manufacturer Date | 2014-05-09 |
| Date Added to Maude | 2016-10-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 | 6026 NICOLLE STREET |
| 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 | 0 |
| Brand Name | CONFORM BINDER SUBMALAR (R) IMPLANT |
| Generic Name | SUBMALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2016-10-27 |
| Model Number | N/A |
| Catalog Number | CBSM-XL |
| Lot Number | 855034 |
| Device Expiration Date | 2019-05-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLE STREET VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-27 |