VISITEC 5192
Received Dec 29, 1997 · Event occurred Nov 6, 1997
Report 1047439-1997-00001 · MDR key 141655
Device
Generic name
Frontalis Suspension Ptosis Set
Manufacturer
Visitec Co.Model number
5192Catalog number
*
Lot number
050996
Product problems
- Break
Patient
62 YR
- Failure of Implant
Narrative
Description of Event or Problem
FRONTALIS SUSPENSION OF THE RIGHT WAS PERFORMED WITH SILICONE ROD ON SUPPLIED PASSING NEEDLES - CARE COMPLETED AND PT TO RECOVERY WITH WELL POSITIONED LID. APPROX 1/2 HR LATER PT NOTED A POPPING IN HER LID AND THE IMMEDIATE DROPPING OF THE LID. SHE WAS TAKEN BACK TO SURGERY AND IT WAS FOUND THAT THE LOOP OF SILICONE HAD BROKEN ON THE MEDIAL LIMB OF THE LOOP NEAR THE LID MARGIN - IT APPEARED TO HAVE JUST FRACTURED. THE WATSKY SLEEVE AND LOCKING STITCH WERE IN PLACE. THE SLING WAS REPLACED WITH ANOTHER SILICONE ROD, AND SHE HAS HAD NO FURTHER SLIPPAGE OR BREAKAGE NOW 5 WK OUT.
Remedial action
- Replace