MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-12-19 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[95745986]
(b)(4). 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
[95745987]
It was reported during preparation for use, the cement hardened before it could be used. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
[113575867]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. The complaint is that the customer went to use the product but it was already hardened. No product was returned and no pictures were provided; therefore the complaint is non-verifiable. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. The following sections were updated: date of this report, unique identifier (udi) #, date received by manufacturer, type of report and follow-up number, follow-up type, device evaluated by manufacturer and not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00891 |
| MDR Report Key | 7129505 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-12-19 |
| Date of Report | 2018-05-21 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2017-12-19 |
| 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 | 2G OTOMIMIX |
| Generic Name | CEMENT, EAR, NOSE AND THROAT |
| Product Code | NEA |
| Date Received | 2017-12-19 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 211190 |
| ID Number | (01)00841036141943 |
| Device Expiration Date | 2019-05-08 |
| 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 | 2017-12-19 |