CD HORIZON® Spinal System 6430530Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169545281), received between Nov 23, 2016 and May 20, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Degraded; Mechanical Jam; Degraded; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4/5 TRANSFOR AMINAL LUMBAR INTERBODY FUSION FOR LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THESET SCREW OF THE LEFT L3 COULD NOT BE REMOVED, SO THE DEVICE WAS TEMPORARILY FIXATED WITH GREAT EFFORT, BUT IT WAS LOOSE AT THE TIME OF THE FINAL FIXATION. EVEN IF THE SET SCREW WAS CHANGED, AND EXECUTION PROCEDURE WAS CHANGED, IT COULD NOT BE DONE AT THE FINAL FIXATION, SO THE SCREW WAS REPLACED. WEAR WAS OBSERVED ON THE THREAD OF SET SCREWS. THERE WAS A DELAY OF LESS THAN 60 MINUTE IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050719 ↗
• MalfunctionDec 13, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR CANAL STENOSIS ASSOCIATED WITH DEGENERATIVE LUMBAR SCOLIOSIS. IT WAS REPORTED THAT, THE HEAD MIGHT HAVE SPREAD OUT WITH CROSS THREADING BECAUSE THE BREAKING OFF OF A SETSCREW COULD NOT BE DONE WHEN THE FINAL WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED. THE LEVELS TREATED WERE L2/3/4/5. PROCEDURE/TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION (OLIF). THE SETSCREWS WERE IDENTIFIED WITH SLIGHT WEAR ON THE THREADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923134 ↗
• MalfunctionDec 13, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR CANAL STENOSIS ASSOCIATED WITH DEGENERATIVE LUMBAR SCOLIOSIS. IT WAS REPORTED THAT, THE HEAD MIGHT HAVE SPREAD OUT WITH CROSS THREADING BECAUSE THE BREAKING OFF OF A SETSCREW COULD NOT BE DONE WHEN THE FINAL WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED. THE LEVELS TREATED WERE L2/3/4/5. PROCEDURE/TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION (OLIF). THE SETSCREWS WERE IDENTIFIED WITH SLIGHT WEAR ON THE THREADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923112 ↗
• MalfunctionDec 13, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR CANAL STENOSIS ASSOCIATED WITH DEGENERATIVE LUMBAR SCOLIOSIS. IT WAS REPORTED THAT, THE HEAD MIGHT HAVE SPREAD OUT WITH CROSS THREADING BECAUSE THE BREAKING OFF OF A SETSCREW COULD NOT BE DONE WHEN THE FINAL WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED. THE LEVELS TREATED WERE L2/3/4/5. PROCEDURE/TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION (OLIF). THE SETSCREWS WERE IDENTIFIED WITH SLIGHT WEAR ON THE THREADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923091 ↗
• MalfunctionMay 27, 2022Mechanics Altered; Mechanics Altered

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521077 ↗
• MalfunctionJun 24, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, AFTER FINAL TIGHTENING OF THE SET SCREW WAS PERFORMED AT L5, WHEN AN ATTEMPT WAS MADE TO PERFORM FINAL TIGHTENING OF THE SET SCREW AT L4, THE SET SCREW IDLED. DUE TO THE INTERFERENCE BETWEEN EXTENDERS, THE IDLED SET SCREW WAS REMOVED, AND THE EXTENDERS WERE REPOSITIONED. THE NEW SET SCREW WAS INSERTED WITHOUT THE INTERFERENCE BETWEEN EXTENDERS, AND THEN FINAL TIGHTENING OF THE SET SCREW WAS PERFORMED WITHOUT PROBLEM. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10192504 ↗
• MalfunctionJun 28, 2019Failure to Align; Device Dislodged or Dislocated; Failure to Align; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-S1 RE-DECOMPRESSION AND FIXATION; AND L4-S1 POSTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, WHILE PERFORMING FINAL TIGHTENING OF THE LEFT SIDE L4 SET SCREW WITH THE DRIVER, THE SET SCREW DID NOT GET CAUGHT BY THE DRIVER. WHEN THE IMAGES WERE CHECKED, SET SCREW WAS FOUND TO BE DEVIATED TOWARDS THE CAUDAL SIDE. THE REPORTED SET SCREW WAS REPLACED WITH A NEW ONE; BUT WHILE INSERTING A NEW SET SCREW, THE TAB OF THE SCREW BROKE. SO, FINAL TIGHTENING COULD NOT BE PERFORMED AT THIS SITE; BUT ALL OF THE LEFT SITES WERE TIGHTENED AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745202 ↗
• MalfunctionNov 6, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR FUSION AFTER OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO PERFORM FINAL TIGHTENING FROM ONE SIDE OF L3, IT COULD NOT BE THREADED BECAUSE OF IDLE. EVEN THOUGH THE SCREW AND SET SCREW WERE REPLACED, IT WAS THE SAME. WHEN INSERTING THE SET SCREW, A LITTLE SQUEAK SOUND WAS HEARD. COUNTER TORQUE WAS USED. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040732 ↗
• MalfunctionNov 6, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR FUSION AFTER OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO PERFORM FINAL TIGHTENING FROM ONE SIDE OF L3, IT COULD NOT BE THREADED BECAUSE OF IDLE. EVEN THOUGH THE SCREW AND SET SCREW WERE REPLACED, IT WAS THE SAME. WHEN INSERTING THE SET SCREW, A LITTLE SQUEAK SOUND WAS HEARD. COUNTER TORQUE WAS USED. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040700 ↗
• MalfunctionNov 5, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR FUSION AFTER OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO PERFORM FINAL TIGHTENING FROM ONE SIDE OF L3, THE SET SCREW COULD NOT BE THREADED BECAUSE OF IDLE. EVEN THOUGH THE SCREW AND SET SCREW WERE REPLACED, IT WAS THE SAME. WHEN INSERTING THE SET SCREW, A LITTLE SQUEAK SOUND WAS HEARD. COUNTER TORQUE WAS USED. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040685 ↗
• MalfunctionNov 1, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR FUSION AFTER OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L3-5 IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO PERFORM FINAL TIGHTENING FROM ONE SIDE OF L3,THE SET SCREW IDLED. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8027286 ↗
• MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH STENOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) SURGERY AT L4-5 LEVELS. DURING SURGERY, THE SET SCREW AT L5 IDLED AT THE FINAL TIGHTENING. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989084 ↗
• MalfunctionSep 11, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A SPINAL FUSION AT L1-L3 DUE TO BURST FRACTURE AT L1-3 OR L2 VERTEBRAL FRACTURE. POST-OP, WHEN BONE UNION WAS ACHIEVED, A REMOVAL SURGERY WAS CONDUCTED. DURING THIS REVISION SURGERY, THE SET SCREW AT THE LEFT SIDE OF L3 WAS FOUND TO BE BROKEN; HOWEVER, IT REMAINED IN THE SCREW HEAD. DUE TO SET SCREW BREAKAGE, THE IMPLANTED ROD DETACHED FROM SCREW HEAD ON THE CAUDAL SIDE. ALL THE IMPLANTS WERE REMOVED IN THE REVISION SURGERY, WITH NO FRAGMENT OF THE BROKEN PRODUCT REMAINING INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854443 ↗
• InjuryJul 31, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH LUMBAR SPINAL CANAL STENOSIS UNDERWENT TRANSVERSE LUMBAR INTERBODY FUSION AT L4/5. POST-OP, ON AN UNKNOWN DATE, THE SET SCREW IN THE RIGHT SIDE OF L4 WAS FOUND TO COMPLETELY BACK OUT OF SCREW HEAD FOR WHICH PATIENT UNDERWENT RE-OPERATION ON (B)(6) 2017. IN THE RE-OPERATION, THE SET SCREWS IMPLANTED IN ONE SIDE WERE REPLACED WITH NEW ONES. THE PATIENT EXPERIENCED NO HEALTH DAMAGE.

  Patient problems: No Code Available

  MAUDE report 6753635 ↗
• MalfunctionNov 23, 2016Failure to Align; Appropriate Device Problem Term/Code Not Available; Failure to Align; Appropriate Device Problem Term/Code Not Available

  LEVELS IMPLANTED- L4-5 PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION SURGERY, THE SET SCREW ROTATED IDLY AND IT COULD NOT BE BROKEN OFF AT FINAL TIGHTENING. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6123869 ↗