ATLAS® Cable System 826-213Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00673978047980), received between Jan 9, 2017 and Nov 2, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF RIGHT PATELLA FRACTURE IN NEED OF SPINAL THERAPY USING CABLES TO FIX THE PATELLA. IT WAS REPORTED THAT DEVICE HAS BROKEN. WHEN USING THE CABLE, THE TOOL TENSION WAS TOO LARGE AND MADE IT BROKE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10768812 ↗
• MalfunctionMay 14, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PATELLA FRACTURE; AND UNDERWENT ARTHRODESIS OF KNEE. INTRA-OP, THE REPORTED CABLE BROKE. THE BROKEN CABLE WAS EXPLANTED WITH NO FRAGMENT OF THE BROKEN PRODUCT REMAINING INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10058305 ↗
• MalfunctionDec 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY FOR FRACTURE. CABLE WAS BEING USED FOR TYING THE PATELLA. INTRA-OP, THE CABLE BROKE. NO FRAGMENT OF THE BROKEN INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9392656 ↗
• MalfunctionJan 7, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: NECK 3-4,4-5 INTERVERTEBRAL DISC PROLAPSE PROCEDURE: POSTERIOR CERVICAL LAMINECTOMY AND CABLE FIXATION IT WAS REPORTED THAT INTRA-OP, PRODUCT WAS BROKEN. PATIENT ACHIEVED SOLID FUSION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224486 ↗
• MalfunctionDec 17, 2018Break; Break

  PROCEDURE: POSTERIOR CERVICAL SINGLE-DOOR SPINAL CANAL DILATATION PRE-OPERATIVE DIAGNOSIS: MULTI-SEGMENT CERVICAL SPONDYLOTIC MYELOPATHY IT WAS REPORTED THAT INTRA-OP, PRODUCT WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170969 ↗
• MalfunctionOct 17, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: HUMERUS FRACTURE IT WAS REPORTED THAT INTRA-OP, INSTRUMENT WAS BROKEN. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINED IN THE PATIENT BODY. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED DURING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975978 ↗
• MalfunctionSep 4, 2018Break; Break

  PRE-OP DIAGNOSIS: AXIAL DISLOCATION WITH INCOMPLETE SPINAL NERVE INJURY, POSTERIOR ARCH NONUNION, LUMBAR 5/ SACRAL 1 DISC HERNIATION PROCEDURE: OPEN REDUCTION OF AXIAL DISLOCATION VIA POSTERIOR APPROACH, DECOMPRESSION OF SPINAL CANAL AND CANTILEVER BEAM INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, A SINGLE CABLE WITH INTEGRAL CRIMP BROKE DURING THE PROCEDURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE ARE NO KNOWN COMPLICATIONS TO THE PATIENT IN THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841130 ↗
• MalfunctionAug 30, 2018Break; Break

  PRE-OP DIAGNOSIS :HUMERUS PATELLAR FRACTURE PROCEDURE: FRACTURE IT WAS REPORTED THAT THE CABLE BROKE INTRA-OPERATIVELY. PATIENT WAS INVOLVED IN THE EVENT BUT NO PATIENT COMPLICATIONS OR SYMPTOMS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831744 ↗
• MalfunctionFeb 19, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: NECK 3,4 CENTRUM OLD FRACTURE LUXATION, LEFT JOINT WAS INTERLOCKING INCOMPETENCE AND NEUROLOGICAL DAMAGE PROCEDURE:CABLE FIXATION IT WAS REPORTED THAT INTRA-OP, THE CABLE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE CABLE WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7279627 ↗
• MalfunctionOct 17, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE CABLE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953929 ↗
• MalfunctionOct 17, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE CABLE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953928 ↗
• MalfunctionOct 17, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE CABLE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953927 ↗
• MalfunctionJan 18, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: ODONTOID FRACTURE, ATLANTO-AXIAL DISLOCATION. FOR WHICH PATIENT UNDERWENT, POSTERIOR CERVICAL REDUCTION, INTERNAL FIXATION SURGERY. INTRA-OP, AT THE END OF THE SURGERY, THE CABLE HAD BREAKAGE AFTER THE PHYSICIAN FIXED AND CUT THE CABLE. THE PHYSICIAN HAD TO USE STEEL WIRE REINFORCEMENT TO COMPLETE THE SURGERY SUCCESSFULLY. THE PRODUCT WAS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6259332 ↗
• MalfunctionJan 9, 2017Break; Break

  IT WAS REPORTED THAT ON 22 NOV 2016, THE PATIENT GOT THE SURGERY DUE TO FRACTURE OF HIP JOINT PROSTHESIS. INTRA-OP, IT WAS FOUND THAT THE PRODUCT BROKE TWO TIMES IN NORMAL TORQUE RANGE. THE PHYSICIAN HAD TO REPLACE A NEW ONE TO COMPLETE THE SURGERY SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6232244 ↗