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 2018-09-06 for HTR * PMI HARSCH LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620845 manufactured by Biomet Microfixation.
[119375617]
(b)(4). Concomitant medical device: biomet microfixation 1. 5 mm system 4 hole extra long straight plate, catalog #: 01-7408, lot #: 259950; biomet microfixation "1. 5 mm" system high torque (ht), sd, x-dr, screw 1. 5 mm x 4 mm, catalog #: 91-6104, lot #: 407720; biomet microfixation unknown screw, catalog #: ni, lot #: ni. Therapy date: (b)(6) 2018. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy. 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: 0001032347-2018-00594 and 0001032347-2018-00595.
Patient Sequence No: 1, Text Type: N, H10
[119375618]
It was reported, a revision surgery was performed due to infection. The infection, subplastical empyema, occurred during rehab after the initial surgery. The devices were removed during the revision surgery. The surgeon requested the htr implant be remade. The distributor stated the doctor indicated that the infection was not related to the implant. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00593 |
| MDR Report Key | 7851074 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-06 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-07-14 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-09-06 |
| 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 HARSCH LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT |
| Product Code | KKY |
| Date Received | 2018-09-06 |
| Model Number | N/A |
| Catalog Number | PM620845 |
| Lot Number | 835210 |
| 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 | 2018-09-06 |