CD HORIZON® Spinal System 8110855Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00721902729331), received between Dec 30, 2016 and Feb 28, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR L1 BURST FRACTURE. PROCEDURE OR THERAPY PERFORMED WAS OPEN LUMBAR FUSION WITH FIXATION AND LAMINECTOMY. IT WAS REPORTED THAT THE SCREW WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. SET SCREW WAS EXPLANTED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13616267 ↗
• MalfunctionDec 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA MEDTRONIC REPRESENTATIVE REGARDING PATIENT IMPLANTED WITH SCREWS DURING PEDICLE SCREW PLACEMENT, WHILE PLACING A CROSSLINK ON A CONSTRUCT AT L3-S1 FOR DEGENERATIVE SPINE. IT WAS REPORTED THAT THE SET SCREWS SHEARED OFF AT THREAD LEVEL INSTEAD OF CAP BREAKING OFF. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT AND DATE OF EXPLANT WAS (B)(6) 2021. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023776 ↗
• MalfunctionJul 30, 2020Break; Break

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR PRE-OP DEGRATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT CROSSLINK WAS BROKEN AND THE SET SCREWS OF THE CROSSLINK WERE SHEARED OFF AND BROKEN. IT WAS MENTIONED THAT, UPON TORQUING THE SET SCREW, THEY NOTICED THAT THE SET SCREW HAD BROKE AND THE BOTTOM PORTION OF THE SET SCREW WAS SHEARED OFF. THE SET SCREW WAS REPLACED AND A SECOND ATTEMPT OF TORQUING TOOK PLACE, AGAIN THE SET SCREW SHEARED OFF. LATER, THEY REMOVED ENTIRE CROSSLINK AND REPLACED A NEW CROSSLINK OF SAME SIZE AND THEN TORQUING WAS SUCCESSFUL. ALL THE BROKEN PARTS OF CROSSLINK AND SETSCREW WERE REMOVED. IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS OF IMPLANT/INSTRUMENT LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS REPORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10342468 ↗
• MalfunctionJan 2, 2020Break; Break

  IT WAS REPORTED AS PER MEDWATCH (REPORT # 5091192) THAT THE PATIENT UNDERWENT FUSION AND LAMINECTOMY/FACETECTOMY. INTRA-OP, WHILE INSERTING A SET SCREW FOR ATTACHING THE CROSSLINK, A SCREW BROKE. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES OF THE BROKEN SCREW; AND A NEW SCREW WAS USED TO SECURE THE CROSSLINK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539936 ↗
• MalfunctionDec 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AND REVISION OF TRANSFORAMINAL LUMBAR INTERBODY FUSION DUE TO STENOSIS. INTRA-OP, WHILE TIGHTENING THE SET SCREW IN THE CROSSLINK, TIP OF THE SET SCREW BROKE OFF. NO FRAGMENT OF THE BROKEN SET SCREW REMAINED INSIDE THE PATIENT; AND NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9509631 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO BACK PAIN. INTRA-OP, WHILE FIXING THE SET SCREW WITH THE 7/32 DRIVER THE SCREW DOESN'T BREAK IN THE RATED BREAK POINT BUT BREAK IN THE THREADED PART. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924609 ↗
• MalfunctionOct 31, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR INSTABILITY AND UNDERWENT FUSION SURGERY. DURING SURGERY,THE TIP OF SET SCREW SHEARED OFF UPON ENGAGEMENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE ALLEGED PRODUCT REMAINED IN THE PATIENT.NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8022654 ↗
• MalfunctionSep 11, 2018Break; Break

  PRE-OP DIAGNOSIS:DEGENERATIVE DISC DISEASE AND SPINAL STENOSIS PROCEDURE: L2-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT INTRA-OP, CROSSLINK SET SCREW BROKE WHILE ATTEMPTING TO BREAK OFF. NO FRAGMENT OF THE BROKEN REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863566 ↗
• MalfunctionDec 1, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AND FUSION AT T2-T9. INTRA-OP, ONE OF THE LATERAL SET SCREWS SPLIT IN TWO. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7074006 ↗
• MalfunctionApr 23, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT LEVELS L4-L5. INTRA-OP, SET SCREW SNAPPED IN HALF WHILE BREAKING OFF WITH T HANDLE AND COUNTER TORQUE.THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515060 ↗
• MalfunctionApr 7, 2017Break; Break

  PRE-OP DIAGNOSIS: LUMBAR FRACTURE PROCEDURE: "POSTERIOR STABILIZATION" LEVELS IMPLANTED:"4" IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE SET SCREW IN THE SURGERY, IT WAS FOUND THAT THE SET SCREW WAS LOOSE. WHEN THE SURGEON WANTED TO TAKE OUT THE SET SCREW, IT BROKE INTO PIECES AND WAS SHATTERED INSIDE THE PATIENT'S BODY. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471168 ↗
• MalfunctionMar 31, 2017Break; Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6448770 ↗
• MalfunctionDec 30, 2016Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE SPINAL STENOSIS UNDERWENT CROSSLINK PLACEMENT AFTER T11 PELVIS FUSION. INTRA-OP, THE SET SCREWS BROKE INTO TWO FRAGMENTS. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6215016 ↗