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.
[94483233]
Zimmer biomet complaint (b)(4). Foreign country - (b)(6). (b)(6). Concomitant medical products - zimmer biomet htr-pmi catalog #: pm619800 lot #: 776370, zimmer biomet thinflap plate catalog #: sp-2046 lot #: 415630, zimmer biomet 1. 5 screw catalog #: 91-6704 lot #: 140670, unknown screws catalog #: ni lot #: ni. Therapy date - (b)(6) 2017. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00866 through 0001032347-2017-00869.
Patient Sequence No: 1, Text Type: N, H10
[94483234]
It was reported a revision was performed due to an infection. It is stated the infection has nothing to do with the implants. A request was received for new htr pmi implants. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00867 |
| MDR Report Key | 7107607 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-12-12 |
| Date of Report | 2018-08-06 |
| Date of Event | 2017-10-11 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-12-12 |