ReLineRecalls & reported problems across all models
Nuvasive, Inc. · 129 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 451
- Deaths reported
- 3
- Injuries reported
- 68
- Recalls
- 0
We found 129 models of ReLine by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 451 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2016 and Jun 16, 2026 — classified as 3 deaths, 68 injuries, 380 malfunctions.
The most frequently reported specific device problem is “Fracture” (200 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 ReLine problems
Device problems
- Fracture200
- Migration or Expulsion of Device41
- Loosening of Implant Not Related to Bone-Ingrowth34
- Migration31
- Detachment of Device or Device Component28
- Unintended Movement25
- Adverse Event Without Identified Device or Use Problem20
- Break17
Patient problems
- No Clinical Signs, Symptoms or Conditions133
- Foreign Body In Patient112
- Failure of Implant90
- Pain54
- No Consequences Or Impact To Patient15
- Insufficient Information9
- Bone Fracture(s)7
- Paralysis6
ReLine models
129 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- ReLine 10000751ORTHOPEDIC MANUAL SURGICAL INSTRUMENT71 reports
- ReLine 13550000Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- ReLine 13600000Orthosis, spinal pedicle fixation, for degenerative disc disease18 reports
- ReLine 10000750ORTHOPEDIC MANUAL SURGICAL INSTRUMENT13 reports
- ReLine 15455500APPLIANCE, FIXATION, SPINAL INTERLAMINAL12 reports
- ReLine 11104055APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death12 reports
- ReLine 10000780ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- ReLine 16026545APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY9 reports
- ReLine 12360500Orthosis, spondylolisthesis spinal fixation7 reports
- ReLine 10000425STIMULATOR, NERVE7 reports
- ReLine 16027545Orthosis, spinal pedicle fixation, for degenerative disc disease7 reports
- ReLine 13116545APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY7 reports
- ReLine 16171111ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- ReLine 10000606ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- ReLine 15360500Orthosis, spinal pedicle fixation, for degenerative disc disease5 reports
- ReLine 10055445APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- ReLine 16017580ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- ReLine 16027540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- ReLine 13116540Orthosis, spondylolisthesis spinal fixation5 reports
- ReLine 16191111Orthosis, spondylolisthesis spinal fixation5 reports
- ReLine 15355500Orthosis, spondylolisthesis spinal fixation4 reports
- ReLine 10000627STIMULATOR, NERVE4 reports
- ReLine 16019580APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- ReLine 16019590APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- ReLine 10001139Orthopedic stereotaxic instrument4 reports
- ReLine D10000332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- ReLine 15355300Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- ReLine 10055440Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- ReLine 13016540APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- ReLine 16016545ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- ReLine 16016550Orthosis, spondylolisthesis spinal fixation3 reports
- ReLine 16024530Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- ReLine 16026550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ReLine 13115540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ReLine 13117540Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- ReLine D10000955STIMULATOR, NERVE3 reports
- ReLine 13450000APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- ReLine 10001118ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- ReLine 11000443Orthopedic stereotaxic instrument3 reports
- ReLine 3900240Posterior cervical screw system2 reports
- ReLine 3904530APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- ReLine 11355035Orthosis, spondylolisthesis spinal fixation2 reports
- ReLine 11355040APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- ReLine 12355300Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 10000607STIMULATOR, NERVE2 reports
- ReLine 10060445Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- ReLine 13015540Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 13016550Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 13045530ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- ReLine 16014540ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- ReLine 16017550Orthosis, spondylolisthesis spinal fixation2 reports
- ReLine 16018510ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- ReLine 16018580APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- ReLine 16025540APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- ReLine 16027550Orthosis, spondylolisthesis spinal fixation2 reports
- ReLine 16087545APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ReLine 10000800STIMULATOR, NERVE2 reports
- ReLine D10000801STIMULATOR, NERVE2 reports
- ReLine 15460500Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 13114540Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 13117535Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- ReLine 13117545APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- ReLine 13117550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ReLine 13119540Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- ReLine 11102255ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- ReLine 11103055Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- ReLine 14514530Thoracolumbosacral pedicle screw system2 reports
- ReLine 3804022Posterior cervical screw system1 report
- ReLine 3804026Posterior cervical screw system1 report
- ReLine 24017545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- ReLine 3900301Posterior cervical screw system1 report
- ReLine 3904012APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- ReLine 3990130Orthopedic manual surgical instrument1 report
- ReLine 3704518APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- ReLine 12355120Pbone cement, posterior screw augmentation1 report
- ReLine 16387555Pbone cement, posterior screw augmentation1 report
- ReLine 11111550Orthosis, spondylolisthesis spinal fixation1 report
- ReLine 10000409ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 14355100Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- ReLine 14355120ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- ReLine 10000481ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 10000483ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 10000615ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 10000718ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 10000745ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 10000747ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ReLine 13014545Orthosis, spondylolisthesis spinal fixation1 report
- ReLine 13015035Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- ReLine 13016545APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ReLine 13017550Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- ReLine 13046030APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ReLine 13065540ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- ReLine 13066540Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- ReLine 16010590APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ReLine 16015535ORTHOSIS, SPINAL PEDICLE FIXATION1 death1 report
- ReLine 16015540Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- ReLine 16015545Orthosis, spondylolisthesis spinal fixation1 report
- ReLine 16016540APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- ReLine 16017540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 death1 report
- ReLine 16024545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent ReLine adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF. THE PIECE WAS LEFT IN, BUT IT WAS FINAL TIGHTENED, SO IT IS WELDED TO THE LOCKING CAP. NO ADVERSE EFFECT TO THE PATIENT AND IT WAS NOT A REVISION.
Patient problems: Foreign Body In Patient
MAUDE report 25522148 ↗MalfunctionJun 15, 2026Disconnection
IT WAS REPORTED THAT DURING A POSTOP ROUTINE PATIENT CONTROL, A FAILURE OF THE INITIAL CONSTRUCT WAS IDENTIFIED BY THE SURGEONS OA. ANDREAS FLOSSMANN AND OA. WACLAV BRUNNER-URBANSKI. RIGHT SIDED ROAD HAS COMPLETELY DISLOCATED FROM THE TULIPS AFTER 3 MONTHS, BUT SET SCREWS ARE STILL IN PLACE. NO INTEROPERATIVE PROBLEMS HAVE BEEN OCCURRING ON THE PRIMARY TREATMENT. NO ISSUES HAVE BEEN DOCUMENTED. PILE DRIVER HAS BEEN USED FOR ALL MONO SCREWS TO SECURE A PROPER FIT OF THE ROD/SCREW/SET SCREW CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 25510710 ↗MalfunctionJun 12, 2026Break
WHEN THE SURGEON WAS TRYING TO FINAL TIGHTEN THE SET SCREWS THE INNER ¿TRACKS¿ OF THE TULIP BEGAN TO SHEAR OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25489384 ↗MalfunctionJun 12, 2026Break
WHEN THE SURGEON WAS TRYING TO FINAL TIGHTEN THE SET SCREWS THE INNER ¿TRACKS¿ OF THE TULIP BEGAN TO SHEAR OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488639 ↗MalfunctionJun 5, 2026Fracture
THE TIP OF THE LOCK SCREW DRIVER BROKE OFF IN THE LOCK SCREW CAP DURING FINAL TIGHTENING. NO ADVERSE EFFECT TO THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE PIECE, AS IT WAS SHEARED OFF FLUSH WITH THE LOCKING CAP.
Patient problems: Foreign Body In Patient
MAUDE report 25411537 ↗MalfunctionJun 5, 2026Fracture
IT WAS REPORTED THAT A RELINE-O FINAL LOCK SCREWDRIVER SHAFT BROKE DURING FINAL TIGHTENING, AND THE TIP WAS COLD WELDED INTO THE SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 25410830 ↗MalfunctionMay 21, 2026Unintended Movement
IT WAS REPORTED THAT A PRIMARY SURGERY TOOK PLACE ON (B)(6) 2026; XLIF AND SPINAL FIXATION AT L2/3/4/5. A SECOND SURGERY WAS PERFORMED BECAUSE THE SCREW HAD DISLODGED. WHEN THE SURGEON ATTEMPTED TO REMOVE THE DISLODGED SCREW, THE SCREW HEAD HAD DETACHED FROM THE SHANK. THE SHANK WAS REMOVED FROM THE BONE, AND THE HEAD AND OTHER PART WERE REMOVED WITH FORCEPS. THERE WAS NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241858 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT DURING SPINAL SURGERY, THE TIP OF T-HANDLE NUVASIVE SCREWDRIVER BROKE OFF WITHIN THE SET SCREW CAP. THE PORTION OF THE SCREWDRIVER TIP WAS FIRMLY POSITIONED IN THE SET SCREW. ATTEMPTS WERE MADE TO REMOVE IT, BUT THE COLD WELDING DISALLOWED EXTRACTION AND RISKS OF FURTHER ATTEMPTS TO EXTRACT WERE DETERMINED TO BE GREATER RISK THAN LEAVING IN PLACE. NO HARM NOTED TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25205427 ↗MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THAT THE TIPS OF BOTH RELINE-O SCREWDRIVERS BROKE OFF IN THE SCREWS DURING THE CASE. TIPS OF DRIVERS REMAIN IN THE SCREWS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163390 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE RELINE MAS FINAL LOCK SCREW DRIVER WAS FRACTURED WHEN THE SURGEON USED IT FOR FINAL TIGHTENING. THE SURGEON COULD NOT REMOVE THE FRAGMENT FROM THE LOCK SCREW AND REMAINS IN THE BODY. THERE WAS NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25126694 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT THE DISTAL STAR TIP OF RELINE FINAL LOCK SCREW DRIVER BROKE OFF IN SET CAP DURING FINAL TIGHTEN. BROKEN PIECE WAS NOT ABLE TO BE RETRIEVED FROM PATIENT. PATIENT WAS NOT HARMED AND WE WERE ABLE TO COMPLETE CASE.
Patient problems: Foreign Body In Patient
MAUDE report 24599005 ↗MalfunctionMar 13, 2026Fracture
A REVISION CASE, SURGEON REMOVED A 7.5X55MM RELINE SCREW AND WANTED TO REPLACE WITH AN 8.5X55 SCREW. TAPPED WITH 7.5 TAPAS THE DOC ALWAYS UNDER SIZES BY 1MM. ADVANCED THE SCREW ABOUT 40/55MM INTO THE PEDICLE AND THE SCREW BECAME SO INCREDIBLY TIGHT IT WOULDN¿T MOVE ANY FURTHER. THE SURGEON HAD NO LUCK REVERSING THE SCREW WITH THE RELINE MAS RED HANDLE, SO ATTEMPTED A SHANK DRIVER FOR MORE LEVERAGE WITH A T-HANDLE. DRIVER TIP COMPLETELY BROKE OFF INSIDE THE SHANK. WE WERE UNABLE TO BACK THE SCREW COMPLETELY OUT. ATTEMPTED TO PUT A SHORT ROD AND SET SCREW INSIDE THE TULIP TO HELICOPTER THE SCREW OUT, HAD TO SNAP THE TOWERS OFF. ROD WAS LOOSE INSIDE THE TULIP, ASSUMING THE DRIVER THAT BROKE OFF WAS PREVENTING A RIGID CONNECTION AND THEREFORE UNABLE TO LOCK THE TULIP INTO A RIGID STATE. WE SUGGESTED TO TAKE THE ENDOSCOPE AND LOOK DIRECTING INTO THE TULIP TO SEE IF WE COULD REMOVE THE BROKEN DRIVER PIECE AND THEN RETRY THE ROD AND HELICOPTER METHOD. THE SURGEON DECIDED NOT TO. A SPINE REMOVAL SET WAS AVAILABLE FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592929 ↗MalfunctionFeb 26, 2026Material Separation
IT WAS REPORTED THAT A 6.0 RELINE SET SCREW FAILED WHILE BEING TIGHTENED DURING AN AIS SCOLI FUSION CASE WITH DR. JON ODA. DR. ODA WAS PROVISIONALLY TIGHTENING THE SET SCREW INTO A HOOK AT THE TOP OF THE CONSTRUCT WHEN HE INDICATED IT FELT STRANGE. UPON REMOVAL A LONG THREAD OF METAL HAD SHEARED OFF BUT WAS STILL ATTACHED TO THE SET SCREW. THIS EXTENDED SURGERY BY APPROX. 30 MINUTES AS THE DOCTOR ATTEMPTED TO REDUCE THE ROD TO THE HOOK AGAIN AND INSERT NEW SET SCREW.
Patient problems: Failure of Implant
MAUDE report 24462118 ↗InjuryFeb 26, 2026Crack
IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2025 DUE TO IMAGING SHOWING THAT THERE WAS HARDWARE FAILURE OF THE LEFT CONNECTOR ROD NEAR L5.
Patient problems: Back pain
MAUDE report 24454381 ↗MalfunctionFeb 25, 2026Fracture
IT WAS REPORTED THAT THE PATIENT HAD INDEX L4-S1 MIS TLIF (B)(6) 2026. TWO WEEKS POST-OP, PATIENT REPORTED HE ¿BENT OVER AND HEARD A POP¿. UPON X-RAY EXAMINATION, THE RELINE MAS MODULAR SCREW HEAD DISASSOCIATED FROM THE RELINE MAS MODULAR SCREW SHANK. THE CONTRALATERAL SET SCREW AT L4 WAS ALSO LOOSE. SCREW REPLACEMENT REVISION TOOK PLACE ON.
Patient problems: Failure of Implant
MAUDE report 24447093 ↗
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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