MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for OTOMIMIX OTOLOGIC CEMENT 70143266 manufactured by Biomet Microfixations.
[156736448]
Otomimix calcium phosphate bottles ref. 70143266, lot# 062650 was returned to service center. There is some powders left inside a plastic bag, but the returned bottles are empty. Both bottles will be sent to the original equipment manufacturer for further investigation. The cause of the reported event cannot determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[156736449]
The user facility reported that during a superior semicircular procedure, prior to use the mixture packaging was opened in the sterile field by the facility? S scrub nurse and crystallization was noted around the rim of the jar. The product was attempted to be mixed according to the instructions for use (mifu). The surgical scrub nurse attempted to mix the powder with 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. The procedure was delayed approximately 30 minutes to source out another product. This event prolonged the patient? S exposure to anesthesia. There were no further issues reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01091 |
| MDR Report Key | 8952699 |
| Date Received | 2019-08-30 |
| Date of Report | 2019-09-25 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-08-30 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTOMIMIX OTOLOGIC CEMENT |
| Generic Name | OTOMIMIX OTOLOGIC CEMENT |
| Product Code | NEA |
| Date Received | 2019-08-30 |
| Returned To Mfg | 2019-08-09 |
| Model Number | 70143266 |
| Lot Number | 062650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATIONS |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-30 |