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 2017-04-26 for OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.
[74012927]
There was no product return for this event. The device history record (dhr) for lot #113270 was reviewed by the (b)(4), he saw no issues with the manufacturing process. This lot produced (b)(4) otomimix units. Xrd testing is performed on the powder for each lot to verify its composition. The amount of powder and liquid is measured and recorded for each vial. An evaluation of the set and hardening times are performed for the powder and liquid component during the manufacturing process. As part of the lot release test, the set and hardening times are also verified for the finished good product. The set times met the requirements. He compared the set times with multiple lots and history of the production process and verified this lot is consistent with the results from multiple lots. The manufacturing process is very consistent; no variation with this lot was identified. The package insert contains mixing instructions. 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.
Patient Sequence No: 1, Text Type: N, H10
[74012928]
It was reported in an ossicular chain reconstruction (ocr) and tympanoplasty procedure on (b)(6) 2016, this was the surgeon's second use of otomimix. At the opening of the first sample, the surgeon felt the components showed a different aspect and mechanical properties; somewhat harder compared to the first use. When she tried to mix them, the aspect remained unusual compared to the previous intervention. When handling the mixture, she felt that it would stick well and hold as expected on the ossicular chain. She therefore decided not to use the first sample and opened the second sample. The exact same observations where made on the second sample and otomimix was eventually not used on the patient. There was no consequence from the use of otomimix on the patient since the mixture was not applied in the middle ear from any of the samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00318 |
| MDR Report Key | 6523225 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-26 |
| Date of Report | 2017-04-26 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2017-04-26 |
| 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 | OTOMIMIX |
| Generic Name | CEMENT, EAR, NOSE AND THROAT |
| Product Code | NEA |
| Date Received | 2017-04-26 |
| Model Number | N/A |
| Catalog Number | 7014-3266 |
| Lot Number | 113270 |
| ID Number | N/A |
| Device Expiration Date | 2018-03-01 |
| 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 | 2017-04-26 |