PROACCESS 03.612.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034714462), received between Sep 12, 2018 and May 4, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Mechanical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A DISCECTOMY. DURING THE PROCEDURE, THE LOCKING MECHANISM ON THE MAST WAS NOT WORKING; IT WAS SPINNING WHEN IN THE LOCKED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069806 ↗
• MalfunctionApr 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON FOUND THAT THE POST WAS NOT SECURELY HOLDING THE POST, IT WAS 'WOBBLY'. THERE WAS NO SURGICAL DELAY AS OTHER SET WAS USED. PATIENT WAS NOT IMPACTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS FURTHER REPORTED THAT A QUANTITY OF TWO OF THE PARTS IN QUESTION WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766284 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON FOUND THAT THE POST WAS NOT SECURELY HOLDING THE POST, IT WAS 'WOBBLY'. THERE WAS NO SURGICAL DELAY AS OTHER SET WAS USED. PATIENT WAS NOT INVOLVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401102 ↗
• MalfunctionMar 7, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE SURGEON FOUND THAT THE POST DID NOT SUFFICIENTLY HOLD THE OTHER POST TO THE OTHER MISSUPPORT. NO PATIENT WAS IMPACTED, AND THERE WERE NO DELAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE PROACCESS(TM) VERTICAL MAST. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494707 ↗
• MalfunctionMar 15, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A COMPLEX CASE THE PROACCESS MAST WAS NO LONGER SUPPORTING THE POST FOR THE MIRA AND THE SYNFRAME RINGS WERE MISSING TWO SCREWS. THE PROCEDURE WAS COMPLETED WITH OTHER SETS. THE PATIENT WAS NOT IMPACTED. THIS REPORT INVOLVES ONE (1) PROACCESS(TM) VERTICAL MAST. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484348 ↗
• MalfunctionMar 15, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A COMPLEX CASE THE PROACCESS MAST WAS NO LONGER SUPPORTING THE POST FOR THE MIRA AND THE SYNFRAME RINGS WERE MISSING TWO SCREWS. THE PROCEDURE WAS COMPLETED WITH OTHER SETS. THE PATIENT WAS NOT IMPACTED. THIS REPORT INVOLVES ONE (1) PROACCESS(TM) VERTICAL MAST. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483928 ↗
• MalfunctionDec 15, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THE SET SCREW IN THE MINIMALLY INVASIVE SURGERY (MIS) PROACCESS VERTICAL MAST WAS NO LONGER FIXED TO THE CLAMP. THE SET SCREW SPUN WHEN TIGHTENING THE CLAMP THUS ALLOWING THE UNKNOWN ROD TO SLIDE THROUGH THE CLAMP AND IT WOULD NOT TIGHTEN PROPERLY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 PROACCESS(TM) VERTICAL MAST. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11006717 ↗
• MalfunctionDec 7, 2020Compatibility Problem; No Apparent Adverse Event; Compatibility Problem; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS DEVICE HAD NO COMPLAINT AGAINST IT. THE COMPLAINED DEVICE WAS THE TABLE CLAMP AND IS CAPTURED ON MANUFACTURER REPORT NUMBER 2939274-2020-05447.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959784 ↗
• MalfunctionJan 30, 2020Component Missing; Component Missing

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) WAS SETTING UP FOR AN ANTERIOR PROCEDURE AND POSTERIOR PROCEDURE. WHERE WE FOUND THAT THE SYNFRAME FOR HALF RING X2 WERE MISSING SCREWS AS WELL AS THE PROACCESS VERTICAL MAST WAS NOT PROPERLY HOLDING THE MIS FLEXARM DESPITE RETIGHTENING THE POST ON THIS INSTRUMENT. THE DOCTOR MANAGED TO MAKE THE INSTRUMENTS WORK FOR HIS PROCEDURES, HOWEVER THESE INSTRUMENTS WOULD NEED TO BE REPLACED. THE PATIENT WAS NOT IMPACTED. NO OTHER INFORMATION IS AVAILABLE FOR REPORTING. CONCOMITANT DEVICE REPORTED: UNKNOWN PROACCESS MIS FLEXARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649286 ↗
• MalfunctionSep 12, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A PRO ACCESS VERTICAL MAST BEGAN TO LOOSEN. AN UNKNOWN SUPPORT FOR THE RETRACTORS HAD TO BE CONSTANTLY TIGHTENED SO THE DEVICE COULD BE USED PROPERLY. THE ISSUE WAS OBSERVED BEFORE THE ONSET OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7869989 ↗