MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for MITTELMAN(R) PRE JOWL CHIN (TM), EXTRA LARGE N/A MPJC-XL manufactured by Implantech Associates, Inc..
[109099829]
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records (assembly and packaging), sterilization process records, and evaluated the 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
[109099830]
Complainant reported that patient had a chin implant explanted approximately 17 months post-operatively due to infection. The reporter indicated the infection appeared to occur in a hollow/void area at the end of the pocket on the left side. The culture on the patient came back positive for pseudomonas aeruginosa. Replacement surgery is tentatively planned after a suitable interval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00004 |
| MDR Report Key | 7538818 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-04-30 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2018-05-23 |
| 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 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 | 0 |
| Brand Name | MITTELMAN(R) PRE JOWL CHIN (TM), EXTRA LARGE |
| Generic Name | CHIN IMPLANT |
| Product Code | FWP |
| Date Received | 2018-05-23 |
| Model Number | N/A |
| Catalog Number | MPJC-XL |
| Lot Number | 845757 |
| Device Expiration Date | 2017-07-01 |
| 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 NICOLLE ST., SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-23 |