PANALOK ORTHOCORD 210024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705000791), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2018Break; Break

  IT WAS REPORTED THAT TWO PANALOK ABSORBABLE 3.5 ANCHORS BROKE WHILE BEING INSERTED DURING A DISTAL BICEPS REPAIR. THE SURGEON DRILLED A PILOT HOLE WITH A 3.2MM PANALOK SPADE TIP DRILL AND SUBSEQUENTLY INSERTED THE ANCHORS. WHEN PULLING ON THE SUTURES TO FIXATE THE ANCHOR AND LOCK IT IN PLACE THE ANCHOR PULLED OUT OF THE PILOT HOLE. THE "WINGS" OR CORNERS OF EACH ANCHOR BROKE OFF AS THE SURGEON PULLED ON THE SUTURES AND THE ANCHOR CAME OUT OF THE BONE. THERE WAS A DELAY OF 20 MINUTES IN THE CASE AS THE FACILITY HAD TO LOCATE MORE ANCHORS. THE REPAIR WAS SUCCESSFULLY COMPLETED BY USING THE SAME DRILL BIT AND A NEW ANCHOR AND NEW ANCHOR HOLE. NO PATIENT CONSEQUENCES. ACTION TAKEN FOR PROCEDURE:THE FACILITY CALLED THE REP TO BRING IN ANOTHER ANCHOR AS THE FACILITY DID NOT HAVE ANY REMAINING ON THE SHELF.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 7382046 ↗
• MalfunctionMar 29, 2018Break; Break

  IT WAS REPORTED THAT TWO PANALOK ABSORBABLE 3.5 ANCHORS BROKE WHILE BEING INSERTED DURING A DISTAL BICEPS REPAIR. THE SURGEON DRILLED A PILOT HOLE WITH A 3.2MM PANALOK SPADE TIP DRILL AND SUBSEQUENTLY INSERTED THE ANCHORS. WHEN PULLING ON THE SUTURES TO FIXATE THE ANCHOR AND LOCK IT IN PLACE THE ANCHOR PULLED OUT OF THE PILOT HOLE. THE "WINGS" OR CORNERS OF EACH ANCHOR BROKE OFF AS THE SURGEON PULLED ON THE SUTURES AND THE ANCHOR CAME OUT OF THE BONE. THERE WAS A DELAY OF 20 MINUTES IN THE CASE AS THE FACILITY HAD TO LOCATE MORE ANCHORS. THE REPAIR WAS SUCCESSFULLY COMPLETED BY USING THE SAME DRILL BIT AND A NEW ANCHOR AND NEW ANCHOR HOLE. NO PATIENT CONSEQUENCES. ACTION TAKEN FOR PROCEDURE:THE FACILITY CALLED THE REP TO BRING IN ANOTHER ANCHOR AS THE FACILITY DID NOT HAVE ANY REMAINING ON THE SHELF.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7382043 ↗