CD HORIZON® Spinal System 7640020Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885074466415), received between Nov 24, 2016 and Jul 18, 2018 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2018Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPONDYLOLISTHESIS AND UNDERWENT REDUCTION AND INTERNAL FIXATION SURGERY. DURING SURGERY THE SET SCREW BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN SET SCREW WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7697673 ↗
• MalfunctionApr 6, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7401879 ↗
• MalfunctionJan 24, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR FUSION SURGERY DUE TO LUMBAR FRACTURE. INTRA-OP, THE SET SCREW SLIPPED AND WAS REPLACED WITH A NEW SET SCREW. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214580 ↗
• MalfunctionJan 23, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION DUE TO FRACTURE OF THORACIC VERTEBRA. INTRA-OP, SET SCREW SLIPPED. THE SET SCREW WAS UNABLE TO BE USED AGAIN SO THE DOCTOR REPLACED THAT WITH A NEW ONE TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211646 ↗
• MalfunctionJan 23, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION DUE TO FRACTURE OF THORACIC VERTEBRA. INTRA-OP, SET SCREW SLIPPED. THE SET SCREW WAS UNABLE TO BE USED AGAIN SO THE DOCTOR REPLACED THAT WITH A NEW ONE TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211642 ↗
• MalfunctionJan 19, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION SURGERY DUE TO SPONDYLOLISTHESIS. INTRA-OP, THE SET SCREW SLIPPED AND SURGEON REMOVED THE SET SCREW FROM THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7204980 ↗
• MalfunctionJan 17, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DISC PROTRUSION AND UNDERWENT LUMBAR POSTERIOR FUSION. DURING SURGERY, THE SET SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7198743 ↗
• MalfunctionJan 15, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SLIPPAGE AND UNDERWENT REPOSITION AND FIXATION OF LUMBAR SLIPPAGE. DURING SURGERY, THE SET SCREWS BROKE. THE BROKEN SET SCREWS WERE REPLACED WITH NEW ONES. NO FRAGMENTS OF BROKEN PRODUCTS 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 7188778 ↗
• MalfunctionJan 15, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SLIPPAGE AND UNDERWENT REPOSITION AND FIXATION OF LUMBAR SLIPPAGE. DURING SURGERY, THE SET SCREWS BROKE. THE BROKEN SET SCREWS WERE REPLACED WITH NEW ONES. NO FRAGMENTS OF BROKEN PRODUCTS 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 7188777 ↗
• MalfunctionJan 11, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR FUSION SURGERY DUE TO LUMBAR SPONDYLOLISTHESIS. DURING THE OPERATION, THE THREAD OF THE TWO SET SCREWS WERE DAMAGED DUE TO WHICH THE SET SCREWS COULDN'T BE IMPLANTED. THEY WERE REPLACED AND THE OPERATION WAS COMPLETELY SMOOTHLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181544 ↗
• MalfunctionJan 11, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR FUSION SURGERY DUE TO LUMBAR SPONDYLOLISTHESIS. DURING THE OPERATION, THE THREAD OF THE TWO SET SCREWS WERE DAMAGED DUE TO WHICH THE SET SCREWS COULDN'T BE IMPLANTED. THEY WERE REPLACED AND THE OPERATION WAS COMPLETELY SMOOTHLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181543 ↗
• MalfunctionDec 5, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH LUMBAR TRAUMA AND UNDERWENT LUMBAR POSTERIOR SURGERY. DURING SURGERY, THE SET SCREW WAS SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE SCREWS CAME IN CONTACT WITH THE PATIENT FOR SEVERAL MINUTES AND WHEN THE SURGEON FOUND THAT IT WAS SLIPPED, SCREW WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081862 ↗
• MalfunctionDec 5, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH LUMBAR TRAUMA AND UNDERWENT LUMBAR POSTERIOR SURGERY. DURING SURGERY, THE SET SCREW WAS SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE SCREWS CAME IN CONTACT WITH THE PATIENT FOR SEVERAL MINUTES AND WHEN THE SURGEON FOUND THAT IT WAS SLIPPED, SCREW WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081861 ↗
• MalfunctionDec 4, 2017Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: DEGENERATIVE LUMBAR SPINE IT WAS REPORTED THAT DURING SURGERY, A SET SCREW SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7078357 ↗
• MalfunctionMay 19, 2017Failure to Align; Failure to Align

  PRE-OP DIAGNOSIS: THORACOLUMBAR FRACTURE PROCEDURE: THORACOLUMBAR FRACTURE INTERNAL FIXATION IT WAS REPORTED THAT, DURING SURGERY, SET SCREW SLIPPED. IT WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577578 ↗
• MalfunctionApr 24, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, THE BREAK-OFF SET SCREW WAS FOUND TO BE SLIPPED. THE SURGEON HAD TO REPLACE IT WITH A NEW ONE TO COMPLETE THE SURGERY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515075 ↗
• MalfunctionJan 23, 2017Break; Break

  IT WAS REPORTED THAT POST-OP, THE IMPLANTED PRODUCT BROKE AND THE BREAKAGE DEVICE IS STILL IN PATIENT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269213 ↗
• MalfunctionNov 28, 2016Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY DUE TO LUMBAR DEGENERATION. INTRA-OP, THE DOCTOR FOUND ONE PRODUCT SLIPPED, HE HAD TO REPLACE IT WITH A NEW ONE TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6130955 ↗
• MalfunctionNov 28, 2016Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY DUE TO LUMBAR DEGENERATION. DURING THE SURGERY,THE DOCTOR FOUND ONE PRODUCT SLIPPED,THE DOCTOR HAD TO REPLACE WITH NEW ONE TO COMPLETE THE SURGERY. PATIENT'S CURRENT STATUS IS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6130953 ↗
• MalfunctionNov 28, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A SURGERY DUE TO LUMBAR FRACTURE. DURING THE SURGERY A SCREW WAS FOUND RUPTURED, THE SURGEON HAD TO REPLACE A NEW ONE TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6128390 ↗
• MalfunctionNov 24, 2016Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY DUE TO LUMBAR DEGENERATION DURING THE SURGERY,THE DOCTOR FOUND THE PRODUCT SLIPPED, HE HAD TO REPLACE NEW ONE TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6127128 ↗
• MalfunctionNov 24, 2016Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT GOT THE SURGERY DUE TO LUMBAR DEGENERATION DURING THE SURGERY,THE DOCTOR FOUND THE PRODUCT SLIPPED, HE HAD TO REPLACE NEW ONE TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6127123 ↗