MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-09-24 for MALLORY / HEAD MODULAR CALCAR RASP / PROVISIONAL N/A 31-108212 manufactured by Biomet Orthopedics.
[1372582]
It was reported that during a hip procedure on (b)(6) 2010, the surgeon was rasping the proximal side of the device when the locking clip loosened and fell out of the provisional. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8783052]
The user facility is outside of the united states. No medwatch report was received. Review of device history records was not possible as lot identification has not been provided. Review of design confirms that normal use of this instrument should not affect the tightness of the clip component; clip is intended to prevent the screw from falling out of the rasp. There is no tool to be used to remove the clip. If device is returned an evaluation will be performed and results will be reported. As device has not been returned, no further evaluation can be performed. This report submitted september 24, 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00397 |
| MDR Report Key | 1844359 |
| Report Source | 01,07 |
| Date Received | 2010-09-24 |
| Date of Report | 2010-09-01 |
| Date of Event | 2010-07-04 |
| Date Mfgr Received | 2010-09-01 |
| Date Added to Maude | 2011-04-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JEREMY SCHROEDER |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743713755 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLORY / HEAD MODULAR CALCAR RASP / PROVISIONAL |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2010-09-24 |
| Model Number | N/A |
| Catalog Number | 31-108212 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-24 |