inforMED
MalfunctionKGS

PRELOADED MINI-REVO ANCHR

Received Dec 24, 1998 · Event occurred Dec 1, 1998

Report 1017294-1998-00054 · MDR key 204304

Device

Generic name

Evo

Manufacturer

Linvatec Corp.

Model number

M74-139-400

Catalog number

C6109A

Lot number

6954

Product problems

  • Break
  • Device, or device fragments remain in patient
  • Tip breakage

Patient

47 YR

  • No Consequences Or Impact To Patient
  • Nonresorbable materials, unretrieved in body
  • Foreign body, removal of

Narrative

Description of Event or Problem

DURING BANKERT REPAIR, DR WAS INSERTING MINI-REVO ANCHOR WHEN THE EYELET BROKE OFF. THE DR WAS ABLE TO RETRIEVE ONE OF THREE SCREWS HE PLACED. HE WAS NOT ABLE TO RETRIEVE THE REMAINING TWO SCREWS.