MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for CONFORM BINDER SUBMALAR (R) N/A CBSM-L manufactured by Implantech Associates Inc..
[112144664]
Evaluation summary attached: method: the actual device was not evaluated, however manufacturing records were reviewed and labeling was evaluated. Results: no failure was detected. Conclusion: the reported events are known inherent risks of the procedure. Product labeling addresses the possibility of extrusion, as well as other complications associated with all surgical procedures, including hematoma.
Patient Sequence No: 1, Text Type: N, H10
[112144665]
Complainant reported that patient had malar implants explanted one week post-operatively due to bilateral extrusion and hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00006 |
| MDR Report Key | 7631666 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-11 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-06-22 |
| 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 ST., SUITE B |
| Manufacturer City | VENTURA CA 90003 |
| Manufacturer Country | US |
| Manufacturer Postal | 90003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Street | 6025 NICOLLE ST., SUITE B |
| Manufacturer City | VENTURA CA 90003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONFORM BINDER SUBMALAR (R) |
| Generic Name | SUBMALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2018-06-22 |
| Model Number | N/A |
| Catalog Number | CBSM-L |
| Lot Number | 870717 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Address | 6025 NICOLLE ST., SUITE B VENTURA CA 90003 US 90003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-22 |