MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-09-07 for ANCHOR FACET SCREW PFF0035 manufactured by Medtronic Spine Llc..
[17410586]
It was reported that a complication was noted during anchor screw placement at l4-l5. The washer got embedded in the wall of the cannula, making it difficult to remove the cannula. With a final pull of the cannula, the tip broke off in the patient. The physician backed out the screw and cannula tip. Nothing was left in the patient. Pedicle screws were used as a new anchor kit was not available. There was no harm to the patient. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
[17816395]
Followed up with company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2011-00114 |
| MDR Report Key | 2235875 |
| Report Source | 05,07 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-08-15 |
| Date of Event | 2011-08-15 |
| Date Mfgr Received | 2011-08-15 |
| Device Manufacturer Date | 2011-05-04 |
| Date Added to Maude | 2011-09-07 |
| 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 | CHERYL CAPES |
| Manufacturer Street | MEDTRONIC SPINE LLC. 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Manufacturer G1 | KYPHON |
| Manufacturer Street | MEDTRONIC SPINE LLC. 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR FACET SCREW |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2011-09-07 |
| Catalog Number | PFF0035 |
| Lot Number | 2257572 |
| Device Expiration Date | 2013-04-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC. |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-07 |