MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-11-21 for QUICKSET MIMIXTM BONE VOID FILLER, 10 GRAM N/A 02-1110 manufactured by Biomet Microfixation.
[60568607]
No pictures were provided and no product was returned for evaluation. The lot number is unknown; therefore the device history records are unable to be reviewed. 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.
Patient Sequence No: 1, Text Type: N, H10
[60568608]
It was reported the mixture did not harden and it had to be rinsed. Upon follow up the sales associate stated the surgeon believes she may not have given the mixture enough time to set. Additional information was requested regarding the event, however no information has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
[65496722]
The complaint is that the mixture did not harden during the procedure. No product was returned. However, in additional correspondences, distributor reports that during a follow-up with the surgeon, the surgeon states that it was her first time using this variation of the product and suggested that she might not have given the mix enough time to set. The ifu (instructions for use) contains instructions to properly mix the product in the section called mixing instructions and approximate mix times in the section titled product mixing times. The most likely underlying cause is user error; the surgeon most likely did not follow the instructions in the ifu.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2016-00681 |
| MDR Report Key | 6118306 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-26 |
| Date Mfgr Received | 2017-01-18 |
| Date Added to Maude | 2016-11-21 |
| 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 | QUICKSET MIMIXTM BONE VOID FILLER, 10 GRAM |
| Generic Name | CALCIUM PHOSPHATE CEMENT |
| Product Code | GXP |
| Date Received | 2016-11-21 |
| Model Number | N/A |
| Catalog Number | 02-1110 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| 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 | 1. Required No Informationntervention | 2016-11-21 |