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 2018-03-14 for OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS N/A 7014-3266 manufactured by Biomet Microfixation.
[102354139]
Zimmer biomet complaint (b)(4). Report source: foreign country (b)(6). 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.
Patient Sequence No: 1, Text Type: N, H10
[102354140]
It was reported during an ossiculoplasty procedure the first batch of otomimix (lot 211240) would not mix well at all and took around two-three (2-3) minutes to turn to a dough like consistency. This batch was placed in the ear and after twenty (20) minutes it had not set. This batch was then removed as it was not working as expected. A sample otomimix that had previously been provided (lot 392710) was mixed and worked correctly. The field was cleaned and dried as much as possible before the cement was used this time. No issues occurred and the cement set within five (5) minutes. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00122 |
| MDR Report Key | 7337777 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-03-14 |
| Date of Report | 2018-08-30 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-03-14 |
| 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 | OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS |
| Generic Name | BONE VOID FILLER |
| Product Code | NEA |
| Date Received | 2018-03-14 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 211240 |
| ID Number | N/A |
| 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 | 2018-03-14 |