CLYDESDALE PTC™ Spinal System 4986855Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169190511), received between Apr 3, 2017 and Sep 9, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Oblique Lumbar Interbody Fusion procedure at L2-5 for spinal canal stenosis. It was reported that the cage was damaged during insertion at L4/5, and it was determined that complete fragment removal would be difficult; hence, fragments reportedly remained in the patient. The treatment was changed to iliac bone grafting and rear fixation, and the procedure was delayed by more than 60 minutes. No further complications were reported in relation to the event. Additional information was received that a broken fragment of part of the damaged cage remained in the body. At the time of insertion, the intervertebral space was narrow and, at L4/5, the ilium was obstructing.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50688131 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH CAGE USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) FOR L3/4 SPONDYLOLISTHESIS SPINE. IT WAS REPORTED THAT THE OLIF CAGE WAS INST ALLED IN THE FRONT AND REAR OPPOSITE DIRECTIONS, WHICH WAS DIFFERENT FROM THE ORIGINAL PROPER USE, AFTER CHANGING THE POSITION FROM THE LATERAL POSITION TO THE PRONE POSITION. THE SURGEON DETERMINED THAT IT WAS VERY UNLIKELY THAT THE DEVICE WOULD AFFECT THE PATIENT, SO IT WAS PLACED IN THE BODY WITHOUT REINSERTION. THE CAUSE OF THE EVENT WAS CONFIRMED AS HUMAN ERROR. THERE WAS NO REVISION SURGERY OCCURRED/ PLANNED AS A RESULT OF THE EVENT. PRODUCT WAS NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640595 ↗
• MalfunctionOct 21, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT CAGE COULD NOT ATTACHED TO INSERTER. PATIENT SYMPTOMS WERE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490759 ↗
• MalfunctionOct 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-5: OBLIQUE L ATERAL INTERBODY FUSION (OLIF) FOR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT WHEN INSERTING THE DD ON L4/5, THERE WAS A STRONG TENSION IN THE ILIUM; IT IS POSSIBLE THAT THE SCREW THREAD OF THE CONNECTION PART WITH THE DD WAS BROKEN WHILE DRIVING IN WITH THE INSERTER. THE POSITIONAL RELATIONSHIP BETWEEN THE INSERTER AND DD STARTED TO BECOME STRANGE, SO THOUGHT IT WOULD DEFINITELY BREAK IF LEFT IT AS IT WAS, SO STOPPED HALFWAY AND REPLACED IT WITH A NEW ONE. THE LEVEL AT WHICH THE IMPLANT WAS PERFORMED L2/3, L3/4, L4/5. THERE WAS AN OVERALL DELAY OF LESS THAN 60 MINUTES IN THE PROCEDURE. 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 17903464 ↗
• MalfunctionJul 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR AN INDICATION OF LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE CAGE WAS BROKEN WHEN IT WAS INSERTED AND DRIVEN INTO THE INTERVERTEBRAL SPACE. THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. 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 17403576 ↗
• MalfunctionFeb 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L2-L3. INTRA-OP, AFTER CAGE INSERTION, A MARKER WAS FOUND NEAR THE RETRACTOR. IT WAS CONFIRMED TO BE A FRAGMENT OF THE CAGE, WHICH WAS RETRIEVED INSIDE THE OPERATIVE FIELD AND WAS DISCARDED IN THE FACILITY. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND THE BONE WAS ALSO HARD DUE TO WHICH THERE WAS RESISTANCE DURING CAGE INSERTION. SO, CAGE INSERTION WAS PERFORMED BY STRONG HAMMERING. NO OPERATIONS SUCH AS TWISTING HAVE BEEN PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT; BUT NO PATIENT COMPLICATIONS WERE REPORTED. THE SURGEON WAS NOT SURE WHETHER THIS EVENT OCCURRED BECAUSE THE BONE WAS HARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9737520 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) AT L3/4 DUE TO INTERVERTEBRAL DISC DEGENERATION AND SPINAL CANAL STENOSIS. INTRA-OP, AT THE TIME OF CAGE INSERTION, THE TIP OF THE CAGE WAS AROUND THE MIDDLE OF THE VERTEBRAL BODY AND IT BECAME UNABLE FOR THE CAGE TO ENTER ANY MORE. IT WAS CHECKED THAT THE CAGE HAD BEEN CRACKED, SO THE CAGE WAS REMOVED. SINCE THERE WERE NO CAGES OF THE SAME SIZE, THE DEFECTIVE CAGE WAS REPLACED WITH A CAGE OF 50MM AND THE CAGE INSERTION WAS PERFORMED. THERE WERE ALSO OSTEOPHYTES AND THE BONE WAS HARD AS WELL. SCRATCHES WERE FOUND AT TITANIUM COATING AND CRACKS SLIGHTLY AHEAD OF THE GRIP. SCRATCHES WERE ON THE THREADS AND DEFORMATION AT THE INSERTER CONNECTION. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9663852 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION DUE TO ADULT DEFORMITY. INTRA-OPERATIVELY, DURING CAGE INSERTION, THE CAGE BROKE. WHEN CHECKING THE IMAGE, DURING INSERTING THE REPORTED PRODUCT AT L3/4 ABOUT 1/3 OF THE CAGE HAD ENTERED IN THE INTERVERTEBRAL DISC SPACE. THE INTERVERTEBRAL DISC SPACE AND THE ENTRANCE WERE BOTH NARROW. IT WAS FELT THAT THE ANGLE AT THE TIME OF INSERTION MIGHT HAD BEEN DEVIATED. THE INSERTION WAS STOPPED, AND THE CAGE WAS REMOVED AND REPLACED WITH THE SAME SIZE PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO FRAGMENT OF THE CAGE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9443321 ↗
• MalfunctionNov 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION AT L4-L5 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, WHEN THE CAGE WAS INSERTED, IT DID NOT ADVANCE FROM THE CONTRALATERAL ANNULAR EPIPHYSIS. THE CAGE INSERTER MOVED IN THE MIDDLE OF INSERTION, DUE TO WHICH THE INSERTER CAME OFF THE CAGE. AFTER THAT, CAGE REMOVAL WAS TRIED BUT THE ATTEMPTS FAILED. THEN, THE SURGEON INSERTED THE CAGE USING ANOTHER INSERTER AND A METAL HAMMER. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME DUE TO THIS EVENT BUT NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329163 ↗
• MalfunctionOct 18, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS; AND UNDERWENT L4-L5 OBLIQUE LUMBAR INTERBODY FUSION (OLIF), P OSTEROLATERAL FIXATION AT L4-L5 USING PERCUTANEOUS PEDICLE SCREW FIXATION. DURING THE SURGERY, THE VERTEBRAL DISC SPACE HEIGHT WAS 6MM. COBB, DISTRACTOR, SHAVER AND CURETTE WERE USED FOR DISSECTING THE INTERVERTEBRAL DISC AND THE TRIAL WAS INSERTED. AFTER THAT, DURING INSERTION OF THE REPORTED CAGE, ONE-FIFTH OF THE POSTERIOR PART OF THE CAGE BROKE. THE BROKEN ONE-FIFTH OF THE CAGE WAS EXPLANTED WHILE THE REST FOUR-FIFTH OF THE CAGE DID NOT MOVE AND REMAINED INDWELT AS IT WAS JUDGED TO BE STABLE. IN THE SPACE CREATED DUE TO BROKEN ONE-FIFTH OF THE CAGE, BONE GRAFT AND LOCAL BONE WAS FILLED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9211232 ↗
• MalfunctionMay 17, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT OBLIQUE LUMBAR INTER-BODY FUSION SURGERY (OLIF) AND PERCUTANEOUS PEDICLE SCREW FIXATION AT L2-L4 DUE TO LUMBAR DISCOPATHY. INTRA-OPERATIVELY, WHILE PERFORMING OLIF AT L3-L4, CAGE BROKE INTO HALF AND ONE HALF REMAINED IN THE PATIENT. WHEN HALF OF THE CAGE ENTERED THE INTERVERTEBRAL SPACE, IT WAS DIFFICULT TO HAMMER IT FOR INSERTION. THE SLEEVE WAS REMOVED WITH A SLEEVE REMOVER, AND IT WAS TRIED TO BE HAMMERED FOR INSERTION AGAIN. HOWEVER, STILL THE CAGE COULD NOT ENTER AND THE CAGE WAS BROKEN AT ABOUT HALF. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7521609 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L3-L5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, WHILE REMOVING THE TRIAL AT L4/5 LEVEL WITH SLAP HAMMER, THE TRIAL HIT THE RETRACTOR BY EXCESSIVE MOTION, AND BLEEDING OCCURRED FROM ARTERY. BY PRESSING WITH GAUZE AND USING INTEGRAN AND FLOSEAL, BLEEDING WAS MANAGED TO BE STOPPED ANYWAY. BUT THE AMOUNT OF BLEEDING WHICH WAS 50CC BY THEN EXCEEDED 500CC AFTER OLIF WAS FINISHED. IT WAS SAID THAT THE SOMATIC ARTERY WAS PROBABLY INJURED. THE DIRECT CAUSE OF THE ARTERIAL INJURY WAS UNKNOWN. IT WAS SAID THAT THERE IS NO PROBLEM WITH THE PATIENT'S POSTOPERATIVE CONDITION.

  Patient problems: Blood Loss

  MAUDE report 7430494 ↗
• MalfunctionDec 20, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WAS PREOPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT UNSPECIFIED SURGERY. DURING SURGERY, THE SURGEON WAS INSERTING A CAGE AT L3/4 USING INSERTER, THE CAGE¿S THREAD PART BROKE, AND INSERTER COULD NO LONGER GRASP THE CAGE. TRIAL WAS USED. (THE HEIGHT WAS SAME SIZE AND THE LENGTH WAS UNDERSIZED). THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7132885 ↗
• MalfunctionApr 3, 2017Break; Break

  PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L3/4/5 IT WAS REPORTED THAT DURING SURGERY, THE CAGE BROKE DURING INSERTION. WHEN THE BREAKAGE OCCURRED, 4/5 OF THE CAGE HAD BEEN INSERTED IN THE VERTEBRAL BODY. SO ONLY 1/5 OF THE BROKEN CAGE COULD BE REMOVED. THIS 1/5 FRAGMENT OF THE CAGE 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 6452722 ↗