MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-10 for HTR-PMI HIRSCH LEFT FRONTAL SPENOID PARIETAL TEMPORAL IMPLANT N/A PM620093 manufactured by Biomet Microfixation.
[96853795]
(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96853796]
It is reported that though the cut edges were acceptable, the hard tissue replacement-patient matched implant (htr-pmi) could not be placed because the brain would not fit; the implant was about three centimeters away. The surgeon alleges the curvature of the implant was wrong. According to the surgeon, the design was created too shallow. "a swelling of the brain lay according to the surgeon not available after removal of the own, osteolytic lid. " the operation was not completed with another device. Neither the first choice nor the backup implants fit. The patient was closed without an implant. The duration of the surgical delay is unknown. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00019 |
| MDR Report Key | 7178674 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-10 |
| Date of Report | 2018-06-26 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2018-05-28 |
| Device Manufacturer Date | 2017-10-26 |
| Date Added to Maude | 2018-01-10 |
| 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 HIRSCH LEFT FRONTAL SPENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2018-01-10 |
| Returned To Mfg | 2018-04-13 |
| Model Number | N/A |
| Catalog Number | PM620093 |
| Lot Number | 790580 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2018-01-10 |