REVOLVE LOCKING CAP
Received Feb 3, 2016 · Event occurred Jan 12, 2016
Report 3004142400-2016-00003 · MDR key 5418980
Device
Product problems
- Migration or Expulsion of Device
Patient
61 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A THOROUGH REVIEW COULD NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. BASED ON THE INFO PROVIDED, IT IS MOST PROBABLE THE ROD BECAME DISLODGED AS A RESULT OF THE LOCKING CAP NOT BEING PROPERLY TIGHTENED ON THE ROD. HOWEVER, WITHOUT THE IMPLANTS TO EVALUATE, NO DEFINITIVE CONCLUSION CAN BE DETERMINED. IF ADD'L INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO GLOBUS THAT A PT HAD A REVISION SURGERY DUE TO A ROD HAVING MOVED OUT OF SCREW TULIP. THE REVISION SURGERY TOOK PLACE (B)(6) 2016.