NA PDL114Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10705034700212), received between Feb 16, 2017 and Jun 22, 2026 — classified as 81 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (63 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 WHILE ASSEMBLING THE INSTRUMENT SET AFTER A CASE IT WAS NOTED THAT THE PDL114 SPREADER'S RATCHETING MECHANISM WAS FOUND NOT TO BE HOLDING THE SPREADER OPEN/LOCKED. THE INSTRUMENT WAS RETURNED ON (B)(6) 2026 AND FUNCTIONALLY TESTED, THE RATCHET MECHANISM IS NOT HOLDING THE TIPS OPEN AS REPORTED. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576743 ↗
• MalfunctionMay 22, 2026Material Integrity Problem

  IT WAS REPORTED ON 24APR2026 BY A DISTRIBUTOR IT WAS DISCOVERED THAT A VERTEBRAL SPREADER HAD A BROKEN RATCHET. THIS WAS DISCOVERED PRIOR TO SURGERY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253944 ↗
• MalfunctionMar 31, 2026Material Integrity Problem

  IT WAS REPORTED THAT ON MARCH 11, 2026, THAT THE PRODUCTS METAL SNAPPED BEFORE STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744426 ↗
• MalfunctionJan 29, 2026Mechanical Problem

  IT WAS REPORTED THE VERTEBRAL BODY SPREADER WAS NOT HOLDING PRESSURE, WHEN SQUEEZING THE HANDLES TO OPEN THE TIP CLOSES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212776 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A QUICK CHECK TO CONFIRM IT IS BROKEN AND IT WAS FOUND THAT THE SPRING IS BROKEN. NO OTHER NOTABLE MALFUNCTION/PROBLEM WITH THIS INSTRUMENT. INSTRUMENT: PDL114, VERTEBRAL BODY SPREADER- ANGLED. LOT: A7OA17.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686860 ↗
• MalfunctionAug 6, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS STICKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729210 ↗
• MalfunctionMay 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS INSTANCES OF 2 KERRISON WITH WELD FAILURE IN THE PINS THAT HOLD THE HANDLE TOGETHER. 1 KERRISON THAT STICKS WHEN SQUEEZING THE HANDLE AND A VERTEBRAL BODY SPREADER THAT IS MISSING A PIN RETURNING FROM THE FIELD. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011808 ↗
• MalfunctionFeb 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS LOOSENESS AT THE PIVOT POINT. IT WAS NOT FOUND DURING A SURGICAL PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306110 ↗
• MalfunctionDec 30, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT RATCHET TUBE WAS MISSING SCREW. THE SPOT WELD BROKE, AND THE SCREW APPEARED TO HAVE BACKED OUT. SPREADER DID NOT STAY OPEN.

  Patient problems: Insufficient Information

  MAUDE report 21036282 ↗
• MalfunctionDec 26, 2024Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019052 ↗
• MalfunctionDec 2, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE LEAF SPRING ON RATCHET PAW BROKEN. SPREADER WILL NOT STAY IN OPEN POSITION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20825377 ↗
• MalfunctionNov 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON OCTOBER 16, 2024 THE LEAF SPRING BROKE IN HALF THUS DISABLING THE RATCHETING MECHANISM. ADDITIONALLY, IT WAS NOTED DURING THE REVIEW THE BACK OF THE SCREW BETWEEN THE INSTRUMENT HEAD AND HANDLES THE TACK WELD IS BROKEN AND HAS VISIBLE RUST IN THAT AREA. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746505 ↗
• MalfunctionNov 6, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE DISTRIBUTOR ON SEP 17,2024 THAT A SET WAS RECEIVED IN THE TERRITORY. THE VERTEBRAL BODY SPREADER IN THE INSTRUMENT SET WAS STICKING. THE CASE WAS CANCELLED, THE INSTRUMENT SET RETURNED UNUSED. THE DISTRIBUTOR DID NOT IDENTIFY THE INSTRUMENT SET, GIVE A LOT # OF THE MALFUNCTIONING NOR PROVIDE ANY OTHER INFORMATION. THE SYSTEM SEARCH DID NOT YIELD AN INSTRUMENT SET RETURNED UNUSED ON OR AROUND SEP 17, 2024. NO FIELD RETURNS WERE MADE AROUND THAT TIME EITHER.

  Patient problems: Insufficient Information

  MAUDE report 20622295 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 WHILE RE-ASSEMBLING THE TRAYS TO BE RETURNED IT WAS NOTICED THE VERTEBRAL BODY RETAINER WAS BROKEN. THIS DID NOT OCCUR DURING THE PROCEDURE THEREFORE NO PATIENT WAS INVOLVED. IT IS UNKNOWN WHEN OR HOW THE DAMAGE OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545454 ↗
• MalfunctionJul 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE A FEW VERTEBRAL BODY SPREADERS WITH BROKEN RATCHET MECHANISMS RETURNING FROM THE FIELD. THESE HAD NOT BEEN REPORTED AS USED IN SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION AT THE WAREHOUSE. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827464 ↗
• MalfunctionJul 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE A FEW VERTEBRAL BODY SPREADERS WITH BROKEN RATCHET MECHANISMS RETURNING FROM THE FIELD. THESE HAD NOT BEEN REPORTED AS USED IN SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION AT THE WAREHOUSE. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827460 ↗
• MalfunctionJul 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE VERTEBRAL BODY SPREADER WAS NOTED TO HAVE A BROKEN LEAF SPRING AT PRE-SURGICAL INSTRUMENT CHECK. IT IS UNKNOWN HOW THE DAMAGE OCCURRED. THERE WAS NO REPORT OF PATIENT HARM WITH REGARD TO THIS INSTRUMENT. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645996 ↗
• MalfunctionMar 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE INSTRUMENT WAS CAME APART AND THE SCREW WAS UNDONE DURING SURGERY. REPORTER IDENTIFIED THAT ANOTHER SPREADER WAS AVAILABLE, SWITCHED OUT THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921365 ↗
• MalfunctionMar 5, 2024Use of Device Problem; Compatibility Problem; Use of Device Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE VERTEBRAL BODY SPREADER WAS MISSING A PIN IN THE ANCHOR THAT ATTACHES THE RATCHETING MECHANISM TO THE HANDLE. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835583 ↗
• MalfunctionFeb 29, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2024, THE SURGEON HAD TWO VERTEBRAL BODY SPREADERS BREAK. THERE WERE NO PATIENT CONSEQUENCES, AND ONLY A MINIMAL TIME WAS ADDED TO THE SURGERY TO REPLACE THE BROKEN INSTRUMENTS. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810764 ↗
• MalfunctionFeb 29, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2024, THE SURGEON HAD TWO VERTEBRAL BODY SPREADERS BREAK. THERE WERE NO PATIENT CONSEQUENCES, AND ONLY A MINIMAL TIME WAS ADDED TO THE SURGERY TO REPLACE THE BROKEN INSTRUMENTS. THIS REPORT INVOLVES ONE VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810762 ↗
• MalfunctionFeb 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WERE MULTIPLE PDL114 VERTEBRAL BODY SPREADERS, RETURNING FROM THE FIELD, WITH MISSING SCREWS AND BROKEN LEAF SPRINGS. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SPREADER- ANGLED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18690627 ↗
• MalfunctionFeb 12, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE MULTIPLE VERTEBRAL BODY SPREADERS, RETURNING FROM THE FIELD, WITH MISSING SCREWS AND BROKEN LEAF SPRINGS. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SPREADER- ANGLED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18690560 ↗
• MalfunctionFeb 12, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE MULTIPLE VERTEBRAL BODY SPREADERS, RETURNING FROM THE FIELD, WITH MISSING SCREWS AND BROKEN LEAF SPRINGS. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18690416 ↗
• MalfunctionFeb 12, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WERE MULTIPLE PDL114 VERTEBRAL BODY SPREADERS, RETURNING FROM THE FIELD, WITH MISSING SCREWS AND BROKEN LEAF SPRINGS. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SPREADER- ANGLED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689683 ↗