MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-10-31 for DEPUY SPINE 3D CROWN SYSTEM 292301001 manufactured by Depuy Spine, Inc..
[960005]
Contact reported that while placing a cervical crown on a patient one of the skull pins became stuck, and could not be advanced or removed. The next day the crown was removed and replaced with another. As the problem could not be quickly resolved an mdr being filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[8210203]
Product has not yet been returned for evaluation. It is unlikely that we will be able to determine a root cause at this time. An event of this nature can occur if the pin is cross thread into the crown. If the device is returned and an evaluation concludes something other than what is stated above a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2008-00184 |
| MDR Report Key | 1218316 |
| Report Source | 01,05,07 |
| Date Received | 2008-10-31 |
| Date of Event | 2008-10-02 |
| Date Mfgr Received | 2008-10-03 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2009-05-07 |
| 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 | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY SPINE 3D CROWN SYSTEM |
| Generic Name | EXTERNAL CERVICAL BRACE |
| Product Code | IQF |
| Date Received | 2008-10-31 |
| Model Number | NA |
| Catalog Number | 292301001 |
| Lot Number | 060511 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-31 |