MaXcessRecalls & reported problems across all models
Nuvasive, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 12 models of MaXcess by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2016 and Jun 30, 2026 — classified as 1 death, 8 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MaXcess problems
Device problems
- Positioning Failure23
- Fracture11
- Mechanical Problem4
- Unintended Movement4
- Loose or Intermittent Connection3
- Smoking3
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Foreign Body In Patient2
- Hemorrhage/Blood Loss/Bleeding2
- Burn(s)1
- Kidney injury1
- Laceration(s)1
- Muscle/Tendon Damage1
- Unspecified Infection1
MaXcess models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MaXcess 3240121ORTHOPEDIC MANUAL SURGICAL INSTRUMENT34 reports
- MaXcess 3240309STIMULATOR, NERVE1 death4 reports
- MaXcess 1011419ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- MaXcess 1025461LIGHT, SURGICAL, FIBEROPTIC2 reports
- MaXcess 3200220LIGHT, SURGICAL, FIBEROPTIC2 reports
- MaXcess 7670214ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MaXcess 1564851STIMULATOR, NERVE1 report
- MaXcess 1606970STIMULATOR, NERVE1 report
- MaXcess 3100154ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MaXcess 1025462LIGHT, SURGICAL, FIBEROPTIC1 report
- MaXcess M4AARMSterilization wrap containers, trays, cassettes & other accessories1 report
- MaXcess 6999110ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent MaXcess adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON WAS DOING A REVISION SURGERY WHERE THE ORIGINAL SURGERY WAS COMPLETED IN 2014 USING ANOTHER COMPANY'S PRODUCTS (MEDACTA) THE SURGEON DID AN XLIF USING THE NUVASIVE MAXCESS 4 RETRACTOR AND INSERTER MODULUS CAGES WITH SINGLE HOLE PLATES ATTACHED AT THOSE TWO LEVELS. HE THEN PROCEEDED TO MOVE THE RETRACTOR UP TO L1/2 AND, WHILST POSITIONING THE RETRACTOR, HE MADE A COMMENT ABOUT THE PATIENT "HOSING BLOOD". HE PACKED THE WOUND USING VARIOUS HEMOSTATIC AGENTS AND GAUZE ON AND OFF FOR APPROXIMATELY 30 MINUTES BEFORE ASKING IF A VASCULAR SURGEON COULD BE CONTACTED AS THE PATIENT CONTINUED TO BLEED. AT THIS POINT DR. ROSENBERG TOLD ME THAT HE WAS GOING TO ABORT ANY INSTRUMENTATION AT L1/2. THE ANESTHETIST APPROXIMATED THAT THE BLOOD LOSS WAS 100-200ML. THE VASCULAR SURGEON SCRUBBED IN AND AFTER APPROXIMATELY AN HOUR OF TRYING TO IDENTIFY AND STOP THE BLEEDING HE DECIDED THAT PATIENT NEEDED TO BE MOVED TO A SUPINE POSITION SO THAT HE COULD GET BETTER VISUALISATION. WHILE IN THIS POSITION THE VASCULAR SURGEON IDENTIFIED THAT THERE WAS A KIDNEY INVOLVED AND THAT THERE WAS GAUZE IN/AROUND ONE OF THE PATIENT'S KIDNEY'S. HE ASKED FOR A GENERAL SURGEON TO BE CALLE
Patient problems: Kidney injury
MAUDE report 25669246 ↗MalfunctionDec 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE RETRACTOR BODY WILL NOT LOCK IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804790 ↗MalfunctionDec 15, 2025Fracture; Fracture
THE PITUITARY BITER BROKE DURING SURGERY, NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804578 ↗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 26, 2025Melted; Smoking; Melted; Smoking
WHEN USING THE LIGHT CABLE IT WAS PLUGGED INTO A LIGHT SOURCE IT STARTED SMOKING AND THE PORTION YOU STICK INTO THE LIGHT BOX MELTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21473002 ↗InjuryFeb 25, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT PERSONNEL IN SPD RECEIVED A CUT ON THEIR HAND FROM A DEVICE PROTRUDING FROM THE CASE WHEN PROCESSING EQUIPMENT. NO INTERVENTION FOR THE CUT WAS REQUIRED. NO FURTHER USER IMPACT WAS REPORTED.
Patient problems: Laceration(s)
MAUDE report 21462648 ↗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 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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