MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-14 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[4688935]
A hospital experienced a significant delay in surgery due to mimix not setting properly.
Patient Sequence No: 1, Text Type: D, B5
[11954287]
There are no prior similar complaints reported with this product type causing a significant delay in surgery. The user facility indicated that the bone cement was discarded intraoperatively as was the packaging so no product is able to be returned to the manufacturer for evaluation. Length of surgical delay of 1 hour is attributed to two units, not a single. The customer indicates that the mixture did not set as intended. The instructions for use indicates proper mixing and setting times. It cannot be verified if these conditions were followed by the user facility. Review of device history records show that lot released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore a facility medwatch report will not be available. 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 event occurred in (b)(6). Distributed quantities for this product for the past 4 years are as follows: 2011 = 3200, 2012 = 2700, 2013 = 3368, 2014 (to date) = 1500. File 2 of 2.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2014-00245 |
| MDR Report Key | 4007886 |
| Report Source | 01,07 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-21 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-07-21 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-08-14 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. AMANDA SISK |
| 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 | 2G OTOMIMIX |
| Generic Name | BONE CEMENT |
| Product Code | NEA |
| Date Received | 2014-08-14 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 954170 |
| ID Number | N/A |
| 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. Hospitalization | 2014-08-14 |