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 2017-10-26 for HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT N/A PM619745 manufactured by Biomet Microfixation.
[90390392]
(b)(4). Review of the device history records shows the lot was released with no recorded anomaly or deviation. The user facility is foreign; therefore a facility medwatch report will not be available. The product was discarded by the hospital and therefore will not be returned for an evaluation. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. This is report one of two for the same event. Report two of two is reported on mfr #0001032347-2017-00774.
Patient Sequence No: 1, Text Type: N, H10
[90390393]
It was reported the surgeon had fitting problems with the patient matched implant. The bone edge was exposed as usual, however, the implant occipital stuck out for approximately 0. 5 centimeters. Even though the surgeon tried to fit the implant several times, however he was unable to resolve the fitting issue. The sales associate stated the bone removal form was followed and to his knowledge the surgeon did not try to burr or modify the implant. The surgery was completed using a handmade bone cement plastic instead. The event resulted in a fifteen minute delay. Further shunt surgeries are planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00773 |
| MDR Report Key | 6982336 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-10-26 |
| Date of Report | 2018-03-30 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2017-10-26 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Generic Name | POLYTETRAFLUOROETHYLENE VITREOUS CARBON, RIGHT FRONTAL SPENOID PARIETAL TEMPORAL |
| Product Code | KKY |
| Date Received | 2017-10-26 |
| Model Number | N/A |
| Catalog Number | PM619745 |
| Lot Number | 775130 |
| ID Number | SEE H10 NARRATIVE |
| 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. Required No Informationntervention | 2017-10-26 |