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 2017-02-09 for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER N/A 02-2025 manufactured by Biomet Microfixation.
[67159427]
Review of device history records show the lot released with no recorded anomaly or deviation. Without a product return, no product evaluation is able to be conducted. 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.
Patient Sequence No: 1, Text Type: N, H10
[67159428]
It was reported the mimix did not perform as intended during a cranioplasty. The surgery was completed using another bone cement not manufactured by zimmer biomet. A thirty minute surgical delay was reported; no injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00094 |
| MDR Report Key | 6314079 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-02-09 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2017-02-09 |
| 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 | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER |
| Generic Name | METHYL METHACRYLATE FOR CRANIOPLASTY; 25G MIMIX |
| Product Code | GXP |
| Date Received | 2017-02-09 |
| Model Number | N/A |
| Catalog Number | 02-2025 |
| Lot Number | 858600 |
| ID Number | N/A |
| Device Expiration Date | 2017-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-02-09 |