PANALOK ANCHOR
Received Sep 5, 2007 · Event occurred Aug 1, 2024
Report 1221934-2007-00235 · MDR key 907568
Device
Generic name
Soft Tissue Fixation Device
Manufacturer
Depuy MitekModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
OUR REP IS REPORTING THAT DURING A ROUTINE POST-OP FOLLOW-UP EXAMINATION FOR A SHOULDER REPAIR, AN X-RAY WAS TAKEN. IT WAS NOTED THAT BOTH THE VERSALOK ANCHOR AND THE PANALOK RC USED 4 WEEKS PREVIOUSLY FOR THE ORIGINAL REPAIR HAD MIGRATED OUT OF THE BONE HOLE INTO THE JOINT SPACE. A REVISION SURGERY HAS YET TO BE SCHEDULED. [THIS MDR IS DIRECTLY ASSOCIATED WITH 1221934-2007-00234, SAME CASE IS ALSO ASSOCIATED 1221934-2007-00230, 1221934-2007-00231, 1221934-2007-00233 & 1221934-2007-00236. THIS IS VIA THE FACT THAT ALL OF THESE EVENTS EMANATE FROM THE SAME FACILITY AND THE SAME SURGEON.]
Additional Manufacturer Narrative
WE HAVE JUST BEEN MADE AWARE OF THIS EVENT AND WE ARE GATHERING INFORMATION TOWARDS CLARITY. A FOLLOW-UP REPORT WILL DETAIL OUR FINDINGS.