ACPRecalls & reported problems across all models
Nuvasive, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 19 models of ACP by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between May 13, 2021 and May 9, 2025 — classified as 3 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Migration” (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 ACP problems
Device problems
- Migration23
- Detachment of Device or Device Component2
- Fracture2
- Migration or Expulsion of Device2
- Device Damaged by Another Device1
- Expulsion1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Dysphagia/ Odynophagia3
- Neck Pain2
- Neck Stiffness2
- Numbness2
- Swelling/ Edema2
- Abdominal Pain1
- Foreign Body In Patient1
ACP models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACP 18008115Appliance, fixation, spinal intervertebral body4 reports
- ACP 18008317Appliance, fixation, spinal intervertebral body4 reports
- ACP 18008113Appliance, fixation, spinal intervertebral body3 reports
- ACP 18008215Appliance, fixation, spinal intervertebral body2 reports
- ACP 18006236Appliance, fixation, spinal intervertebral body2 reports
- ACP 18006120Appliance, fixation, spinal intervertebral body2 reports
- ACP 18008315Appliance, fixation, spinal intervertebral body2 reports
- ACP 18009358Appliance, fixation, spinal intervertebral body1 report
- ACP 18009356Appliance, fixation, spinal intervertebral body1 report
- ACP 18009352Appliance, fixation, spinal intervertebral body1 report
- ACP 18009234Appliance, fixation, spinal intervertebral body1 report
- ACP 18008617Appliance, fixation, spinal intervertebral body1 report
- ACP 18008515Appliance, fixation, spinal intervertebral body1 report
- ACP 18008117Appliance, fixation, spinal intervertebral body1 report
- ACP 18009348Appliance, fixation, spinal intervertebral body1 report
- ACP 18006234Appliance, fixation, spinal intervertebral body1 report
- ACP 18006240Appliance, fixation, spinal intervertebral body1 report
- ACP 18009116Appliance, fixation, spinal intervertebral body1 report
- ACP 8785319Appliance, fixation, spinal intervertebral body1 report
Recent ACP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Mechanical Problem; Mechanical Problem
ON (B)(6) 2025 A PATIENT UNDERWENT AN ANTERIOR CERVICAL INTERBODY FUSION AT AN UNKNOWN LEVEL. ON (B)(6) 2025 SCREWS WERE NOTED TO HAVE BACKED OUT AND THE PLATE WAS REPLACED POSSIBLE LOCKING MECHANISM FAILURE DOESN'T SEEM TO STAY LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21998584 ↗MalfunctionMar 20, 2025Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C5 TO C7. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2025, IT WAS DISCOVERED DURING A POST OP FOLLOW UP THAT THE PLATE LOCKING MECHANISMS HAD NOT RETAINED THE SCREW AT C7 AND THE SCREW HAD BACKED OUT. TO DATE THERE IS NOT PATIENT IMPACT AND NO REVISION SURGERY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657330 ↗MalfunctionOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON AN UNKNOWN DATE A PATIENT UNDERWENT AN 3-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT C4/C7. FOLLOW UP POSTOPERATIVE RADIOGRAPH SUGGEST THE LOCKING MECHANISM HAD DETACHED FROM THE IMPLANTED PLATE. NO REVISION SURGERY PLANNED; SURGEON WILL MONITOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20485709 ↗InjuryMar 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2023, A FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL INTERBODY FUSION AT C5 TO C7 INCLUDING AN ACP PLATE AND SCREWS, 2 PEEK SPACERS FROM ANOTHER MANUFACTURER AS WELL AS AUTOGRAFT WITHOUT ISSUE, HOWEVER SEVERAL DAYS AFTER THE PROCEDURE THE PATIENT STARTED EXPERIENCING A REACTION. (BODY ACHES, PAIN AND SWELLING, HEAD ACHES, SICK TO STOMACH) POST REACTION ALLERGY TESTING IDENTIFIED A SEVER REACTION TO NICKLE. THE PATIENT IS WORKING WITH HER SURGEON AND ALLERGIST ON A PLAN BUT WANTS TO KNOW THE MATERIALS INVOLVED IN HER PRODUCTS.
Patient problems: Abdominal Pain; Headache; Neck Pain; Rash; Swelling/ Edema
MAUDE report 18847328 ↗MalfunctionJan 10, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Noise, Audible; Migration; Migration or Expulsion of Device; Detachment of Device or Device Component; Noise, Audible; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT C3-C5. SUBSEQUENTLY, ON AN UNKNOWN DATE APPROXIMATELY SEVEN (7) MONTHS POST-OP, THE PATIENT COMPLAINED OF CLICKING IN THEIR NECK. RADIOGRAPH IMAGES WERE OBTAINED AND IT WAS DISCOVERED THAT THE LOCKING MECHANISM ON THE PLATE APPEARED TO HAVE FAILED AND AT LEAST ONE SCREW HAD BACKED OUT AT C5 AND POTENTIALLY ONE OR BOTH SCREWS AT C3. THE SURGEON WANTS TO REVISE THE PATIENT; HOWEVER, NO REVISION PROCEDURE HAS BEEN SCHEDULED AS THE SURGEON STATED THE PATIENT HAS NOT BEEN COMPLIANT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484758 ↗InjuryDec 29, 2023Migration; Migration
ON (B)(6) 2023 A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL "DISCECTOMY" FUSION. ABOUT 3 MONTHS POST-OP THE PATIENT WENT TO THE ER DUE TO FLUID BUILD UP. ON (B)(6) 2023 A REVISION SURGERY WAS CONDUCTED WHERE IT WAS DISCOVERED A SCREW BACKED OUT OF THE PLATE CAUSING A SMALL ESOPHAGEAL TEAR. THE BACKED OUT SCREW WAS REPLACED AND A C4/7 POSTERIOR CERVICAL FUSION WAS CONDUCTED. NO ADDITIONAL ISSUES REPORTED.
Patient problems: Laceration(s) of Esophagus; Perforation of Esophagus; Swelling/ Edema
MAUDE report 18422677 ↗MalfunctionAug 2, 2023Migration; Migration
ON (B)(6) 2023 A CERVICAL PROCEDURE WAS CONDUCTED UTILIZING AN ANTERIOR FIXATION PLATE WITH NO REPORTED PROBLEM. ON (B)(6) 2023 IT WAS DISCOVERED THAT A SCREW BACKED OUT OF THE PLATE. THE PATIENT WILL HAVE A FOLLOW-UP NEXT MONTH. NO REVISION SURGERY IS SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446252 ↗MalfunctionAug 1, 2023Migration; Migration
THIS COMPLAINT WAS DISCOVERED DURING REVIEW OF OLDER COMPLAINTS THAT WAS MISSED AS IT WAS REPORTED IN AMONGST ANOTHER REPORTED EVENT: ON A (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C4 TO C6. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON A (B)(6) 2022 DATE IT WAS DISCOVERED DURING A POST-OP FOLLOW UP X-RAY THAT A PLATE SCREW HAD BACKED OUT AT THE C6 LEVEL. THE PATIENT WAS EXPERIENCING NO ADVERSE EFFECTS AS A CONSEQUENCE OF THE ISSUE AND NO REVISION IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17437793 ↗MalfunctionJun 15, 2023Migration or Expulsion of Device; Device Damaged by Another Device; Expulsion; Material Deformation; Migration or Expulsion of Device; Device Damaged by Another Device; Expulsion; Material Deformation
AN ACP SCREW BACK OUT 1 YEAR POST OP. THEY DID THE REVISION SURGERY TODAY TO REMOVE THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17137367 ↗MalfunctionOct 18, 2022Migration; Migration
ON (B)(6) 2022 A SPINAL PROCEDURE WAS CONDUCTED. ON (B)(6) 2022 RADIOGRAPHS WERE TAKEN WHICH REVEALED A SCREW AND PLATE BACKED OUT. NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15627364 ↗MalfunctionOct 18, 2022Fracture; Fracture
WE HAD AN ACP PLATE REMOVAL TODAY DUE TO SCREW BACK OUT AND NON-UNION. ACP PLATE AND MODULUS IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2021 AND THE PATIENT WAS BROUGHT BACK ON (B)(6) 2022 DUE TO SCREWS NOTICEABLY BACKING OUT ON IMAGING. THE CAM LOCK WAS FRACTURED- THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621527 ↗MalfunctionAug 24, 2022Material Separation; Material Separation
ON (B)(6) 2021 A PATIENT UNDERWENT A ANTERIOR CERVICAL PLATING PROCEDURE FROM C5-C7 AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE DURING A ROUTINE ONE YEAR POST-OP APPOINTMENT IT WAS DISCOVERED THAT THE SCREWS WERE BACKING OUT AT C7. ON (B)(6) 2022 A REVISION OCCURRED IN TO REMOVE ADDRESS THE BACKED OUT SCREWS. UPON REMOVAL OF THE ANTERIOR PLATE IT WAS OBSERVED THAT THE LOCKING MECHANISM HAD SEPARATED FROM THE PLATE RESULTING IN THE SCREWS LOOSENING. THE PLATE AND SCREWS WERE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15285222 ↗MalfunctionJul 14, 2022Fracture; Fracture
ON (B)(6)2022, THE HEAD OF AN ACP SCREW SHEERED WHILE INSERTING. THE SCREW SHANK WAS LEFT IN PLACE. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 15015749 ↗MalfunctionApr 1, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C5-C6 USING AN INTERBODY AND ANTERIOR PLATING CONSTRUCT. SUBSEQUENTLY, A POST-OPERATIVE EVALUATION PERFORMED APPROXIMATELY TWO (2) WEEKS LATER IDENTIFIED ONE OF THE ANTERIOR PLATE SCREWS IN THE C6 VERTEBRAL BODY HAD BACKED OUT. THE PATIENT INITIALLY REPORTED DIFFICULTY SWALLOWING; HOWEVER, AN EVALUATION AT THREE (3) WEEKS POST-OP IDENTIFIED THE PATIENT'S CONDITION TO BE IMPROVING. THERE IS NO INTENT TO REVISE THE CONSTRUCT AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 13972436 ↗MalfunctionMar 29, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL ANTERIOR CERVICAL PLATE FIXATION PROCEDURE. SUBSEQUENTLY, A POST-OPERATIVE EVALUATION PERFORMED APPROXIMATELY THREE (3) MONTHS LATER IDENTIFIED BOTH SCREWS AT THE BOTTOM LEVEL APPEARED TO BE BACKING OUT. THERE IS NO INTENT TO REVISE THE CONSTRUCT AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13944161 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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