MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-12-12 for HTR-PMI KOVALIOVAS RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM619804 manufactured by Biomet Microfixation.
[94482278]
Zimmer biomet complaint (b)(4). (b)(4). Concomitant medical products- zimmer biomet htr-pmi catalog #:pm619800 lot #: 776370. Therapy date - (b)(6) 2017. Foreign country - (b)(6). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00863.
Patient Sequence No: 1, Text Type: N, H10
[94482279]
It was reported during implantation of bilateral htr implants, it was noticed that the implants did not fit without over-compressing the brain. It is still unclear whether it is due to the swelling of the brain or the implants design being too flat. The presumption of the surgeon is the implants are too shallow. Different methods were used to attempt to get the implants to fit, this resulted in a surgical delay of approximately 45 minutes. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00864 |
| MDR Report Key | 7107583 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-12-12 |
| Date of Report | 2018-08-06 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2017-12-12 |
| 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 KOVALIOVAS RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2017-12-12 |
| Model Number | N/A |
| Catalog Number | PM619804 |
| Lot Number | 776380 |
| ID Number | SEE NARRATIVE IN H10 |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2017-12-12 |