MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-06-14 for FIRST CHOICE HEAD 16.0-STEM 5.5 DRUJ-610-1655-WW manufactured by Ascension Orthopedics.
[3468321]
During surgery, when impacting the device, the surgeon felt the head on the implant was not the same size as the trial device or the size the box (containing the device) claimed it to be. A second implant of the same size and lot number was available which was the correct size and was used to complete the surgery. There was no pt injury. However, there was a reported 20 min delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
[10863446]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00014 |
| MDR Report Key | 3181624 |
| Report Source | 05,07 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-06-14 |
| Date of Event | 2013-05-23 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-09-11 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRST CHOICE HEAD 16.0-STEM 5.5 |
| Generic Name | FIRSTCHOICE DRUJ |
| Product Code | KXE |
| Date Received | 2013-06-14 |
| Catalog Number | DRUJ-610-1655-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-14 |