MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-22 for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER N/A 02-2025 manufactured by Biomet Microfixation.
[83240972]
The product was implanted into the patient and therefore will not be returned. It was confirmed that the expiration date was not checked by the surgical team prior to implantation. If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[83240973]
It was reported the product was implanted into the patient on (b)(6) 2017; subsequently it was identified the product expiration date is april 2017. It was confirmed by the sales representative that there was no issue or patient injury. It was confirmed that the expiration date was not checked prior to implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00688 |
| MDR Report Key | 6810575 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-08-01 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2017-08-22 |
| 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, 25 G MIMIX |
| Product Code | GXP |
| Date Received | 2017-08-22 |
| Model Number | N/A |
| Catalog Number | 02-2025 |
| Lot Number | 695910 |
| ID Number | N/A |
| Device Expiration Date | 2017-04-01 |
| 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 | 1. Other | 2017-08-22 |