MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-08 for HTR *PMI CORSI LEFT FRONTAL PARIETAL TEMPORAL IMPLANT N/A PM621333 manufactured by Biomet Microfixation.
[135554187]
Zimmer biomet complaint (b)(4). (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as 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
[135554188]
It was reported that the implant did not fit well. There were several possibilities that may have caused this issue, but it is thought that the implant was a bit off. It did not seem to have enough curve to it. When the implant was aligned against the anterior portion of the defect, the posterior side of the implant would lip up about four to five millimeter and vice versa. There was no way to get it to sit flush. So, the surgeon cut four centimeters off the posterior side and filled the gap with bone cement. There was a delay of approximately thirty minutes. No adverse events have been reported as a result of the malfunction. The surgeon was satisfied with the end result and no issues have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00096 |
| MDR Report Key | 8320844 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-02-08 |
| Date of Report | 2019-07-18 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2018-10-10 |
| Date Added to Maude | 2019-02-08 |
| 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 | 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 | 3 |
| Brand Name | HTR *PMI CORSI LEFT FRONTAL PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT |
| Product Code | KKY |
| Date Received | 2019-02-08 |
| Model Number | N/A |
| Catalog Number | PM621333 |
| Lot Number | 862700 |
| 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 | 2019-02-08 |