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 2019-02-15 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[136258902]
Zimmer biomet complaint (b)(4). Unique identifier (udi) number: (b)(4). Foreign country: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136258903]
It was reported that upon mixing the product, it did not have the correct consistency. The packaging was opened in sterile fashion by the scrub nurse. The scrub nurse then passed it to the surgical scrub team to prepare the bone filler; the scrub nurse had not opened the jar. The liquid jar was opened in normal fashion and crystallization was noted around the rim of the jar. The surgical scrub team attempted to mix the powder with the liquid and it did not seem to have enough liquid. The bone filler did not have the correct consistency and was unable to be used. Alternative product was opened since they did not have the same product for replacement. This caused a delay of approximately thirty minutes. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00106 |
| MDR Report Key | 8342949 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-02-15 |
| Date of Report | 2019-06-24 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-06-05 |
| Device Manufacturer Date | 2018-06-20 |
| Date Added to Maude | 2019-02-15 |
| 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 | 2019-02-15 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 062650 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-02-15 |