Shoulder System 04.01.0161Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040706483), received between Dec 14, 2018 and Feb 12, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fracture

  DURING DRILLING THE POLYAXIAL SCREW HEAD BROKE OFF. THE SURGEON REMOVED THE PROTRUDING PORTION AND LEFT THE REST OF THE SCREW IN PLACE. SURGERY WAS COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 1 HOUR AND 50 MINUTES, AND THE DELAY TIME WAS 20 MINUTES. PATIENT`S BONE WAS REPORTED TO BE VERY HARD. JUST ONE ADDITIONAL SCREW HAS BEEN IMPLANTED OTHER THAN THE BROKEN ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321119 ↗
• MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PRONGS OF THE GLENOID POLYAXIAL LOCKING SCREW DEFORMED DURING SCREW INSERTION IN THE SUPERIOR PART OF THE BASEPLATE USING GRS GLENOID POLYAXIAL SCREWDRIVER (REF04.01.10.0646) FOR SCREW INSERTION ANDMODULAR SCREWDRIVER - T10 TIP - SMALL AO(REF04.01.10.0270) FOR FINAL TIGHTENING. THE SCREW HAD TO BE CUT OFF. THE ISSUE CAUSED 30 MIN DELAY (TOT TIME SURGERY 120 MIN). PATIENT & RSQUO'S BONE QUALITY REPORTED TO BE FIRM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655149 ↗
• InjuryJul 21, 2023Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE BASEPLATE, WHICH HAD ALSO NOT INTEGRATED WITH THE BONE. UPON OPENING THE PATIENT, IT WAS ALSO NOTED THAT ONE OF THE TWO L30 SCREW HAD BROKEN (IT IS UNKNOWN WHICH ONE BROKE). THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS WITH COMPETITOR COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17368998 ↗
• MalfunctionSep 18, 2019Material Twisted/Bent; Material Twisted/Bent

  DURING THE PRIMARY REVERSE SHOULDER SURGERY AND WHILE INSERTING THE 30MM GLENOID POLYAXIAL LOCKING SCREW, THE TABS ON THE SCREW HEAD BENT CAUSING THE SCREW NOT TO SEAT OR LOCK. THE SURGEON REMOVED THE SCREW AND WAS ABLE TO SUCCESSFULLY IMPLANT, SEAT AND LOCK THE NEW SCREW. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9080726 ↗
• MalfunctionJun 19, 2019Material Fragmentation; Material Fragmentation

  DURING THE REVERSE SHOULDER CASE, DR (B)(6) DRILLED INTO THE GLENOID. HE THEN PUT A 30MM SCREW INTO THE HOLE. HE ADMITS IT WAS SLIGHTLY ANGLED BUT IT WAS STILL AN ANGLE THAT THE DRILL GUIDE ALLOWED HIM TO DRILL. AS HE APPLIED THE TORQUE SCREW DRIVER TO THE SCREW (THE SMALL ONE) TO LOCK IT IN, THE HEAD OF THE SCREW (THE SMALL ONE) SNAPPED OFF INSIDE THE PATIENT. THE TORQUE SCREW DRIVER HADN'T EVEN CLICKED YET SO HE WASN'T USING ANY EXCESS FORCE IN ANY WAY. HE WAS ABLE TO RECOVER THE PIECE OF THE SCREW BUT THE REST OF THE SCREW WAS THEN LEFT IN SITU AS IT WASN'T INTERFERING WITH THE IMPLANT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8712080 ↗
• MalfunctionApr 4, 2019Material Deformation; Material Deformation

  WHILE THE SURGEON WAS SCREWING THE GLENOID POLYAXIAL LOCKING SCREW IN THE BASEPLATE, SUDDENLY, THE SCREWDRIVER HAD NO MORE GRIP ON TO THE SCREW, THE SCREW PRONGS WERE DEFORMED. IT WAS NOT POSSIBLE TO SCREW OR UNSCREW THE GLENOID POLYAXIAL LOCKING SCREW ANYMORE, THE SURGEON HAD TO BREAK THE PRONGS IN ORDER TO PLACE THE GLENOSPHERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482794 ↗
• MalfunctionDec 14, 2018Fracture; Fracture

  DURING SURGERY THE PRONGS OF THE GLENOID POLYAXIAL LOCKING SCREW BROKE. THE PRONGS AND THE INNER LOCKING SCREW WERE REMOVED, THE BODY OF THE OUTER LOCKING SCREW WAS LEFT IN PLACE. THE BREAKAGE OF THE SCREW HAPPENED WHEN IT CAME IN CONTACT WITH THE METAGLENE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164768 ↗