MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-06 for BINDER SUBMALAR (R) IMPLANT N/A BSM-M manufactured by Implantech Associates, Inc..
[88707625]
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records, and product labeling. Results: no failure was detected. Conclusion: the possibility of infection is a known, inherent risk associated with implant surgery.
Patient Sequence No: 1, Text Type: N, H10
[88707626]
Complainant reported that patient complained of left cheek tenderness and had left side cheek implant explanted due to infection approximately 3 months post-operatively. No culture was taken, so no organism has been identified. As of (b)(6) 2017, physician felt infection appears to be resolved. Note: the complainant reported that rhinoplasty, neck lift, lip lift, mandible and forehead contouring with brow lift and scalp advancement were cited as concomitant medical therapies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2017-00006 |
| MDR Report Key | 6923692 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-06 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2017-10-06 |
| 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, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, 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 | BINDER SUBMALAR (R) IMPLANT |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2017-10-06 |
| Model Number | N/A |
| Catalog Number | BSM-M |
| Lot Number | 869223 |
| 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 STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-06 |