MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-28 for KYPHON ANCHOR FACET SCREW SYSTEM PFF0001 manufactured by Medtronic Sofamor Danek Usa, Inc.
[3041960]
It was reported that during a posterior spinal procedure at l3/l4, the surgeon experienced difficulty advancing the drill through the patient's bone and remarked that "the drill bit seemed to get dull very quickly. " as the surgeon continued drilling, the cannula got very hot from the friction. At the end of the procedure, a small burn mark was observed on the patient's skin in the area where the cannula touched the skin. The burned area was treated with wound dressings. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[10343331]
(b)(6). (b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2012-02461 |
| MDR Report Key | 2848563 |
| Report Source | 05,07 |
| Date Received | 2012-11-28 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-10-29 |
| Date Mfgr Received | 2012-10-29 |
| Device Manufacturer Date | 2012-06-09 |
| Date Added to Maude | 2012-11-28 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON ANCHOR FACET SCREW SYSTEM |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2012-11-28 |
| Model Number | NA |
| Catalog Number | PFF0001 |
| Lot Number | WI12G029 |
| Device Expiration Date | 2014-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINNEA RD. MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-28 |