inforMED
MalfunctionKGS

SUPER REVI IMPLANT, PRELOADED SUTURE

Received Aug 16, 2005 · Event occurred Jul 21, 2005

Report 1017294-2005-00164 · MDR key 703737

Device

Generic name

Super Revo

Manufacturer

Linvatec Corp.

Model number

NA

Catalog number

C6141

Lot number

UNK

Product problems

  • Break
  • Difficult to Insert

Patient

28 YR

  • Foreign body, removal of

Narrative

Description of Event or Problem

DURING A BANKART AND SLAP PROCEDURE, THE ANCHOR BROKE DURING INSERTION AT THE SUPERIOR PROXIMAL PART. THE ANCHOR WAS IMMEDIATELY RETRIEVED FROM THE SOFT TISSUE WITH NO INJURY.