MaXcess 3240121Recalls & reported problems
Nuvasive, Inc. · MaXcess 4 Articulating Arm · Class 1
Quick summary
This Nuvasive MaXcess articulating arm is a surgical retractor arm used to hold tissue back during spine surgery. The 34 reports mostly describe the arm failing to lock or tighten properly, staying loose or losing rigidity mid-procedure, and in one case a cracked attachment point that led to a cancelled surgery. There are no deaths and 3 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00887517196668), received between Sep 16, 2022 and Dec 15, 2025 — classified as 3 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (22 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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure22
- Fracture5
- Loose or Intermittent Connection3
- Mechanical Problem3
- Unintended Movement3
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ARM IS NO LONGER RIGID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804014 ↗MalfunctionAug 25, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING SURGERY THE ARTICULATING ARM WAS LOOSE, EVEN AFTER TIGHTENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883587 ↗MalfunctionMar 26, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3 TO L5. DURING THE PROCEDURE THE RETRACTOR ARM WAS UNABLE LOCK WHEN TIGHTENED. THE ARM WAS SWAPPED FOR A BACKUP AND SURGERY COMPLETED WITH NO FURTHER PROCEDURE OR PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21699646 ↗MalfunctionFeb 4, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN EXTREME LATERAL INTERBODY FUSION PROCEDURE, THE LOCKING MECHANISM ON THE RETRACTOR ARM MAINTAIN A RIGID POSITION AND COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY WITH NO PATIENT OR PROCEDURE IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305797 ↗MalfunctionNov 22, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ARTICULATING ARM ON A RETRACTOR WAS NOT LOCKING IN PLACE AND WAS RIGID DURING A PROCEDURE. THE DEVICE WAS ABLE TO BE EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT OR CASE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20764225 ↗MalfunctionNov 22, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ARTICULATING ARM OF A RETRACTOR WOULD NOT SECURE IN PLACE AS THE ATTACHMENT MECHANISM WAS CRACKED AND AS A RESULT THE PROCEDURE WAS CANCELLED. NO INFORMATION WAS ABLE TO BE OBTAINED ON WHETHER THE PATIENT HAD RECEIVED ANESTHESIA PRIOR TO THE DISCOVERY OF THE ISSUE. NO INFORMATION WAS ABLE TO BE OBTAINED ON WHETHER THE PROCEDURE HAS BEEN RESCHEDULED OR OTHERWISE COMPLETED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763533 ↗MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A PROCEDURE IT WAS FOUND THAT ATTACHMENT OF THE RETRACTOR BODY TO THE ARM WAS LOOSE AND WOULD NOT BECOME RIGID WHEN LOCKED. MO IMPACT TO THE PATIENT OR CASE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19932474 ↗MalfunctionJun 7, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON WAS UNABLE TO TIGHTEN AN ARM TO THE RETRACTOR BODY AND THE ASSEMBLY REMAINED LOOSE. ANOTHER RETRACTOR WAS USED TO COMPLETE THE CASE WITH NO IMPACT TO THE PATIENT OR PROCEDURE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488315 ↗MalfunctionMar 13, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE ARTICULATING ARM WAS UNABLE TO BE TIGHTENED TO MAINTAIN RIGIDITY. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18899713 ↗MalfunctionMar 13, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE ARTICULATING ARM WAS UNABLE TO BE TIGHTENED TO MAINTAIN RIGIDITY AT THE JOINT CLOSEST TO THE RETRACTOR. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18899698 ↗MalfunctionMar 8, 2024Positioning Failure; Positioning Failure
NEW AND UPDATED INFORMATION LISTED ON SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870850 ↗MalfunctionFeb 23, 2024Positioning Failure; Positioning Failure
NEW OR UPDATED INFORMATION LISTED ON SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773470 ↗MalfunctionDec 18, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE ARM WOULD NOT LOCK DOWN, CAUSING THE RETRACTOR ATTACHMENT TO STAY LOOSE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18352564 ↗MalfunctionNov 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE RETRACTOR ATTACHMENT COMPONENT BROKE OFF OF THE ARM. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18178782 ↗MalfunctionNov 6, 2023Positioning Failure; Positioning Failure
NEW OR UPDATED INFORMATION LISTED ON SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080900 ↗MalfunctionOct 20, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE ARM WOULD NOT TIGHTEN. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17980908 ↗MalfunctionSep 15, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE ARM DID NOT LOCK, RESULTING IN THE ARM NO LONGER BEING ABLE TO MAINTAIN RIGIDITY TO HOLD THE RETRACTOR IN PLACE. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17760456 ↗MalfunctionSep 8, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING SURGERY, THE ARM WAS NOT TIGHTENING WHEN THE SURGEON ATTACHED THE ARM TO THE RETRACTOR AND CONTINUED MOVING EVEN WHEN THE SURGEON TIGHTENED THE ARM ALL THE WAY DOWN. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17716184 ↗MalfunctionSep 1, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ARTICULATING ARM WOULD NOT STAY TIGHT DURING A PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17674429 ↗MalfunctionAug 28, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED DURING THE XLIF PROCEDURE TO INSERT CAGES INTO L1/5, THE TIP OF THE ARM COULD NOT BE LOCKED IN ORDER TO SECURE THE RETRACTOR. SINCE THERE WAS NO SPARE ARM, THE PROCEDURE WAS PERFORMED WITH THE TIP TAPED AND SECURED. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17635073 ↗MalfunctionAug 9, 2023Positioning Failure; Positioning Failure
NEW OR UPDATED INFORMATION LIST IN SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17491565 ↗MalfunctionJun 29, 2023Positioning Failure; Positioning Failure
NEW OR UPDATED INFORMATION LISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17234314 ↗MalfunctionJun 28, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON WAS POSITIONING THE RETRACTOR, THE DISTAL PORTION OF THE ARTICULATING ARM WAS UNABLE TO TIGHTEN IN ORDER TO RIGIDLY MAINTAIN THE RETRACTOR'S POSITION. THE PROCEDURE WAS COMPLETED USING COMPETITOR PRODUCT. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221392 ↗MalfunctionMay 31, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem
CORRECTED INFORMATION LISTED IN SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17035185 ↗MalfunctionMay 17, 2023Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement
DURING A SPINAL PROCEDURE, THE ARTICULATING JOINT WOULD NOT LOCK WHEN ARM JOINT AND RETRACTOR ATTACHMENT ARE BOTH ENGAGED. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946540 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.