MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for WIDENING MANDIBULAR ANGLE(TM) N/A WMA-5L manufactured by Implantech Associates, Inc..
[133936414]
Evaluation summary attached: method: the actual device was not returned, however production records were analyzed which including sterilization records, labeling, environmental monitoring, and historical data review. Results: no failure of the device itself was reported or found during investigation. Conclusions: the reported events are known inherent risks of device and associated surgical procedures. Labeling addresses the possibility of complications such as infection and extrusion.
Patient Sequence No: 1, Text Type: N, H10
[133936415]
Complainant reported that patient complained of pain and swelling on the left side approximately 1 week after having mandibular angle implants placed bilaterally. Physician suspected possible infection and patient was treated with antibiotics (amoxicillin p. O. ) and pain medications (toradol p. O. ) over the next several weeks. Approximately 1 month post-operatively, the patient reported that he spat up the left side device while gargling. Complainant reports that device appears intact. No culture was taken. Patient is doing fine and has no symptoms of infection, and surgery to replace the left side device has been scheduled. (note: explant date listed is represents date device completely extruded out of the patient. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2019-00001 |
| MDR Report Key | 8271469 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-10-27 |
| Date Mfgr Received | 2018-12-26 |
| Device Manufacturer Date | 2016-02-25 |
| Date Added to Maude | 2019-01-23 |
| 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 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 | 0 |
| Brand Name | WIDENING MANDIBULAR ANGLE(TM) |
| Generic Name | MANDIBULAR IMPLANT |
| Product Code | FWP |
| Date Received | 2019-01-23 |
| Model Number | N/A |
| Catalog Number | WMA-5L |
| Lot Number | 865024 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-01-23 |