MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-09-07 for CUSTOM MADE DEVICE BERG CUSTOM MANDIBLE ONLAYS N/A CP-3018 manufactured by Biomet Microfixation.
[119640274]
Zimmer biomet complaint (b)(4). (b)(4). Implant date: (b)(6) 2017. Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119640275]
It was reported the patient stated she is dissatisfied with the implant and a revision is planned. The patient stated that she believes that the implant was not bent properly and as a result, the left side of her chin is bigger and "it looks like a ball coming out of my face. " she stated that she is scheduling a revision for (b)(6). She stated the original procedure occurred in (b)(6) 2017. The sales representative stated the surgeon is not dissatisfied with the design or fit of the implant. However, due to the patient's concerns, a new implant was requested. The revision has not yet been scheduled. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00604 |
| MDR Report Key | 7856821 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-09-07 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2017-10-03 |
| Date Added to Maude | 2018-09-07 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CUSTOM MADE DEVICE BERG CUSTOM MANDIBLE ONLAYS |
| Generic Name | CUSTOM MADE MANDIBLE |
| Product Code | HWJ |
| Date Received | 2018-09-07 |
| Model Number | N/A |
| Catalog Number | CP-3018 |
| Lot Number | 786780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-07 |