CLYDESDALE PTC™ Spinal System 4986050Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169190726), received between Mar 28, 2017 and Feb 13, 2025 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED FOR POSTERIOR FIXATION. LEVELS IMPLANTED WAS TH4-L5. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS SCOLIOSIS. IT WAS REPORTED THAT THE CAGE HAS COME LOOSE TO THE EXTENT THAT IT IS PIERCING INTO THE MUSCLE. PROCEDURE PERFORMED WAS REVISION SURGERY DUE TO DD DISLOCATION. MEDTRONIC PRODUCTS WERE NOT INVOLVED IN THE INITIAL SURGERY HAPPENED ON (B)(6) 2019. REOPERATION PLANNED AS A RESULT OF THE EVENT ON (B)(6), 2025 AND DURING THE REOPERATION WILL UNDERGO DD REMOVAL AND AUTOLOGOUS ILIUM TRANSPLANTATION. PATIENT SYMPTOMS ARE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CAGE WAS COMING OUT SO MUCH THAT IT WAS STUCK IN THE MUSCLES. PATIENT WAS NOT RECOVERED YET. THE POSTOPERATIVE CONDITION AFTER ADDITIONAL SURGERY WHICH HAPPENED ON 31(B)(6) 2025 WAS UNKNOWN. DURING THE ADDITIONAL SURGERY, DD WAS REMOVED, THE AUTOLOGOUS ILIAC BONE WAS TRANSPLANTED, AND THE OPERATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372683 ↗
• MalfunctionJul 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4/5 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LCS. IT WAS REPORTED THAT THE INTERVERTEBRAL INLET WAS NARROW AND DID NOT ENTER SMOOTHLY DURING INSERTION; IT WAS REMOVED FROM THE SURGICAL FIELD. WHEN CHECKING THE CONNECTION BETWEEN THE IMPLANT AND THE INSERTER ON THE TABLE, A CRACK WAS OBSERVED ON THE IMPLANT, SO THE SIZE WAS CHANGED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE IMPLANT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS. THE ISSUE MAY HAVE OCCURRED DUE TO PATIENT FACTOR AND CANNOT BE SAID TO BE USER ERROR. THE SIZE CHOICE WAS CORRECT AND NO USER ERROR. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642281 ↗
• MalfunctionJun 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAGE HA VING L4/5 OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING THE INSERTION OF THE SPACER, THE CONNECTION BECAME LOOSE AND IT WAS THEN DISCOVERED THAT A SMALL FRAGMENT HAS FRACTURED OFF THE IMPLANT. THE SURGEON RETRIEVED THE FRACTURED PIECE FROM THE PATIENT AND IT WAS DISCARDED. THERE WAS A DELAY OF LESS THAN 10 MINUTES IN OVERALL PROCEDURE TIME AND NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. 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 19575046 ↗
• MalfunctionSep 29, 2023Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED CAGE. IT WAS REPORTED THAT, CAGE FRACTURED AT INTERFACE WITH INSERTER. ON IMPLANTING SECOND CAGE AND WHEN MALLEATING, THE INSERTER DISENGAGED FROM CAGE WITH A FRAGMENT OF CAGE STILL ATTACHED. THE CAGE WAS INSERTED FULLY WITH A MAKE DO IMPACTOR. THERE WERE NO FRAGMENTS OF BROKEN CAGE LEFT INSIDE PATIENT BODY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE AT LEVEL L2/3 AND 3/4. PROCEDURE OR TECHNIQUE PERFORMED WAS DIRECT LATERAL INTERBODY FUSION. BROKEN PIECE OF CAGE WAS DISPOSED OFF BY THE FACILITY. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841700 ↗
• MalfunctionDec 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OBLIQUE LUMBAR INTERBODY FUSION FOR ADJACENT SEGMENT DISEASE. IT WAS REPORTED THAT CAGE BROKEN DURING SURGERY. WHEN AN ATTEMPT WAS MADE TO IMPLANT THE CAGE IN A DIRECTION ALONG THE END PLATE AND THE VERTEBRAL BODY TILTED INTENSELY, THE ANGLE OF THE INSERTER WAS ATTACHED TO THE CAGE, AND THE LOAD WAS APPLIED TO THE CAGE. IN THAT STATE, IT WAS REMOVED, AND ABOUT HALF OF IT WAS INSERTED INTO THE CAGE. THE CAGE WAS BROKEN AND COULD NOT BE GRASPED WITH A REMOVER, AND IT WAS REMOVED USING A KOCHER. LESS THAN 60 MINUTES DELAY HAPPENED DUE TO THIS EVENT. LEVELS IMPLANT PERFORMED L3/4. NO IMPLANT DEBRIS LEFT IN THE PATIENT'S BODY. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892067 ↗
• MalfunctionOct 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-5 OLIF FOR LOW BACK PAIN. IT WAS REPORTED THAT WHEN CLEANING AFTER THE COMPLETION OF THE OLIF PROCEDURE, A BROKEN PIECE LIKE A PLASTIC THING WAS FOUND. IT WAS SPECULATED TO BE PART OF CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586223 ↗
• MalfunctionOct 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-5 OLIF FOR LOW BACK PAIN. IT WAS REPORTED THAT WHEN CLEANING AFTER THE COMPLETION OF THE OLIF PROCEDURE, A BROKEN PIECE LIKE A PLASTIC THING WAS FOUND. IT WAS SPECULATED TO BE PART OF CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586212 ↗
• MalfunctionMay 7, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LUMBAR CANAL STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L3-L4. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND THERE HAD BEEN LOAD. INTRA-OP, WHEN THE CAGE WAS BEING HAMMERED IN, THE GRIPPING OF THE INSERTER AND THE INSERTER KNOB BECAME LOOSE. SO, THE CAGE WAS REMOVED, AND IT WAS FOUND THAT THE THREADED PART OF THE CAGE HAD BEEN BROKEN. HENCE, ANOTHER CAGE WAS OPENED AND WAS IMPLANTED USING THE SAME INSERTER. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME DUE TO DIFFICULTY IN REMOVING THE CAGE AND THEN INSERTING A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033042 ↗
• InjuryMay 5, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L1-L3 LUMBAR CANAL STENOSIS; AND UNDERWENT L1-L3 OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AND L1-L3 POSTERIOR FIXATION. INTRA-OP, THE ENDPLATE BROKE WHILE CURETTING THE INTERVERTEBRAL DISC. OLIF WAS BEING PERFORMED USING THE O-ARM AND NAVIGATION SYSTEM. UNDER DIRECT VISION, THE POSITION OF THE VERTEBRA DISC WAS CONFIRMED UNDER NAVIGATION. THE OLIF RETRACTOR WAS PLACED, AND THE COBB, SHAVER, CURETTE, AND OLIF INSERTER: ALL INSTRUMENTS WERE USED. OLIF WAS PERFORMED AT L1-L2, L2-L3. AFTER CHANGING THE PATIENT'S POSITION, THE SURGEON CHECKED THE IMAGE TO CONFIRM THE LEVEL, AND IT WAS CONFIRMED THAT THE CAGE TO BE PLACED AT L1-L2 WAS INDWELT IN THE L1 VERTEBRA BODY (NEAR THE LOWER ENDPLATE). NO DEVIATION IN THE NAVIGATION WAS NOTED, BUT THE INTERVERTEBRAL DISC SPACE WAS ORIGINALLY NARROW (ABOUT 4 MM) AND THE ENDPLATE MAY HAVE BEEN BROKEN WHILE CURETTING THE INTERVERTEBRAL DISC. IN THE SURGEON'S OPINION, THE EVENT OCCURRED BECAUSE CHECK ON THE C-ARM DURING THE OLIF OPERATION WAS NEGLECTED. AS A RESULT OF THIS EVENT, INTERBODY BONE GRAFTING WAS DONE FROM THE POSTERIOR SIDE OF L1-L2. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDUR

  Patient problems: Bone Fracture(s)

  MAUDE report 10025106 ↗
• InjuryFeb 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS. SHE UNDERWENT COMBINED ANTERIOR-POSTERIOR FIXATION AT L3-L5, OBLIQUE LUMBAR INTERBODY FUSION AT L3-L4 AND L4-L5, RIGHT/LEFT PERCUTANEOUS PEDICLE SCREW FIXATION AT L3-L5 IN DECUBITUS POSITION AND L3-L4 COMPRESSION. NAVIGATION AND FLUOROSCOPY WAS USED IN THIS PROCEDURE. INTRA-OP, AFTER THE CAGE WAS PLACED AT L3-L4, THE IMPLANT WAS FOUND TO BE PROTRUDED ABOUT 5-10 MM FROM THE ANTERIOR EDGE OF THE VERTEBRAL BODY. THIS WAS FOUND WHEN CHECKING SAGITTAL FLUOROSCOPY IMAGE. IT WAS ALSO JUDGED THAT THE ANTERIOR LONGITUDINAL LIGAMENT (ALL) RUPTURED; AND HENCE, THE IMPLANT WAS IMMEDIATELY REMOVED AND WAS REPLACED WITH ANOTHER CAGE OF 14MM HEIGHT. THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT.

  Patient problems: Injury

  MAUDE report 9701250 ↗
• InjuryFeb 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT POST-OPERATIVE FEVER AND CT/MRI WAS TAKEN FOR THE SUSPICION OF INFECTION. THE PATIENT WAS DIAGNOSED WITH ILIOPSOAS MUSCLE ABSCESS BETWEEN L4 AND L5, AND FOREIGN SUBSTANCE REMOVAL WAS PERFORMED. THE PATIENT HAD A FEVER DUE TO THE OPERATIVE INFECTION WITH THE DIAGNOSIS OF ILIOPSOAS MUSCLE ABSCESS BETWEEN L4 AND L5. THE PROCEDURE OF REMOVAL WAS A REVISION SURGERY.

  Patient problems: Fever

  MAUDE report 9664104 ↗
• MalfunctionNov 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) OF 2 INTERVERTEBRAL DISCS AND ANTEROPOSTERIOR FIXATION AT L3/4/5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, DURING CAGE INSERTION THE GRASPING OF THE CAGE GOT LOOSE SUDDENLY WHEN HITTING. THE THREADED INSERTER HOLE OF THE CAGE WAS STRIPPED. IT WAS JUDGED THAT THE GRASPING PART OF THE INSERTER AND THE THREAD OF THE CAGE BROKE AND A NEW CAGE IN SAME SIZE WAS OPENED TO DEAL WITH IT. THE NEWLY OPENED CAGE TURNED TO A SIMILAR STATE, BUT IT WAS INSERTED AS IT WAS. THE INTERVERTEBRAL DISC SPACE WAS NOT NARROW, AND THE SURGEON CANNOT DECIDE THE SIZE FROM 8 OR 10 AND THE CAGE OF 10 WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353697 ↗
• MalfunctionNov 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) OF 2 INTERVERTEBRAL DISCS AND ANTEROPOSTERIOR FIXATION AT L3/4/5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, DURING CAGE INSERTION THE GRASPING OF THE CAGE GOT LOOSE SUDDENLY WHEN HITTING. THE THREADED INSERTER HOLE OF THE CAGE WAS STRIPPED. IT WAS JUDGED THAT THE GRASPING PART OF THE INSERTER AND THE THREAD OF THE CAGE BROKE AND A NEW CAGE IN SAME SIZE WAS OPENED TO DEAL WITH IT. THE NEWLY OPENED CAGE TURNED TO A SIMILAR STATE, BUT IT WAS INSERTED AS IT WAS. THE INTERVERTEBRAL DISC SPACE WAS NOT NARROW, AND THE SURGEON CANNOT DECIDE THE SIZE FROM 8 OR 10 AND THE CAGE OF 10 WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353635 ↗
• MalfunctionNov 9, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) AT L4/5 DUE TO LUMBAR CANAL STENOSIS (LCS). INTRA-OP, THE DIRECTION OF THE CAGE (THE DORSAL SIDE AND THE VENTRAL SIDE) GOT REVERSED. AFTER THE INSERTION AT L3/4, IT WAS ATTEMPTED TO REMOVE THE CAGE USING AN INSTRUMENT OF L4/5 STANDARD, BUT FAILED. SO DRILLED THE CAGE INTO SMALL PARTS AND REMOVED THE CAGE. THE REMOVED CAGE WAS CHIPPED ABOUT 1/5 AND THE REMAINING PARTS WERE MISSING DUE TO WASHING. NEW PRODUCT WAS OPENED AND USED. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9301800 ↗
• MalfunctionNov 2, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF), POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AND PERCUTANEOUS PEDICLE SCREW FIXATION (PPS) AT L3/4/5 DUE TO LUMBAR DEGENERATIVE KYPHOSCOLIOSIS. INTRA-OPERATIVELY, THE CAGE WAS BROKEN. IT HAPPENED WHEN THE SURGEON WAS INSERTING THE INSERTER TO THE CAGE DURING OLIF. THE TIP OF THE BIOPSY NEEDLE (MANUFACTURED BY OTHER MEDICAL DEVICE MANUFACTURER) WAS DEVIATED WHEN THE SURGEON STARTED PERFORMING THE PROCEDURE OF PPS AND DUG DEEP, IT CAUSED THE PATIENT'S BLOOD PRESSURE TO DROP. THE SURGEON REMOVED THE TWO SCREWS THAT HAD BEEN IMPLANTED ALREADY AND PERFORMED SUTURE. ADDITIONAL SURGERY WAS PERFORMED BY A CARDIOVASCULAR SURGEON. HE FOUND THAT THERE WAS A HOLE IN THE ARTERY WHICH WAS CAUSED BY THE BIOPSY NEEDLE. THE SURGEON REPAIRED THE INJURED PART OF THE VESSEL AND CLOSED THE WOUND. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THE CAGE BREAKAGE DURING PLIF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9269920 ↗
• MalfunctionSep 3, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L2-S2. INTRA-OP, WHEN INSERTING THE CAGE AT L2-L3, THE GRIPPING PART OF THE CAGE BROKE NEAR THE INSERTION POINT OF THE VERTEBRAL BODY. THE TRIAL OF SAME SIZE WAS INSERTED, BUT THE INSERTION POINT OF THE VERTEBRAL BODY WAS NARROW. THE BROKEN CAGE WAS REPLACED WITH ANOTHER CAGE OF SAME SIZE. NO FRAGMENT OF THE BROKEN CAGE REMAINED IN THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8956702 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5 DUE TO DEGENERATIVE LUMBAR SCOLIOSIS AND SPINAL CANAL STENOSIS. INTRA-OP, WHILE INSERTING THE CAGE AT L4/5, THE CAGE BROKE AFTER THE SURGEON HIT THE CAGE ABOUT 3 TIMES WITH A HAMMER. THE CAGE BROKE AT THE POINT WHERE IT CONNECTS WITH THE INSERTER. THE BROKEN CAGE WAS COMPLETELY REMOVED AND REPLACED WITH A NEW ONE. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821042 ↗
• MalfunctionJul 12, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) SURGERY AT L3/4 DUE TO LCS( LUMBAR CANAL STENOSIS) LAMINECTOMY. INTRA-OP, THREADS OF THE CAGE WERE BROKEN. AFTER INSERTING THE CAGE AT L3/4, THE INSERTER CAME OFF THE CAGE WHEN THE SURGEON WAS TRYING TO REMOVE THE CAGE IN ORDER TO ADJUST THE POSITION. NEW CAGE WAS OPENED AND USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8783789 ↗
• MalfunctionApr 9, 2019Break; Break

  PRE-OPERATIVE: DEGENERATIVE SCOLIOSIS. PROCEDURE: L2-5 OLIF (OBLIQUE LATERAL INTERBODY FUSION). IT WAS REPORTED THAT INTRA-OP, AT L3/4 AND AT L4/5, WHEN CAGE WAS INSERTED TO THE INDICATED POSITION, IT WAS FELT THE INSERTER WAS LOOSE. WHEN SHOOK SIDEWAYS, IT WAS FOUND THAT THE CAGE WAS BROKEN. CAGE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494759 ↗
• MalfunctionApr 9, 2019Break; Break

  PRE-OPERATIVE: DEGENERATIVE SCOLIOSIS. PROCEDURE: L2-5 OLIF (OBLIQUE LATERAL INTERBODY FUSION). IT WAS REPORTED THAT INTRA-OP, AT L3/4 AND AT L4/5, WHEN CAGE WAS INSERTED TO THE INDICATED POSITION, IT WAS FELT THE INSERTER WAS LOOSE. WHEN SHOOK SIDEWAYS, IT WAS FOUND THAT THE CAGE WAS BROKEN. CAGE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494754 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION DUE TO DEGENERATIVE KYPHOSCOLIOSIS AT L2/3. INTRA-OP, WHEN HAMMERING THE CAGE, THE THREAD GOT LOOSENED PROBABLY. AS A RESULT OF CONTINUOUS HAMMERING THE THREAD BROKE AND THE CAGE GOT OUT OF CONTROL. THE THREAD PART OF INSERTER WAS NOT USED AND THE CAGE WAS CAUGHT WITH THE CLAW PART OF THE TIP. ADDITIONAL HAMMERING WAS DONE AND THE CAGE WAS INSTALLED. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7637127 ↗
• MalfunctionMay 9, 2018Metal Shedding Debris; Metal Shedding Debris

  TYPE OF PROCEDURE OR TECHNIQUE USED : 2/3 OLIF 5/S PLIF IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, DURING THE INSERTION OF THE CAGE, THE CONNECTING PART BETWEEN THE CAGE AND THE INSERTER RUBBED, SCRAPINGS LIKE PEEK PIECES APPEARED IN THE OPERATIVE FIELD. THE SURGEON SAW THE PROBLEM OF THE CAGE THAT GENERATED SHAVINGS WITH LITTLE LOAD. NO FRAGMENT REMAINED IN PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498511 ↗
• MalfunctionDec 27, 2017Break; Break

  PRE-OP DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS OPERATED: L2/3, L3/4 IT WAS REPORTED THAT DURING SURGERY, THE GRASPING MECHANISM OF THE CAGE BROKE. IT WAS CONFIRMED THAT INSERTER COULD NO LONGER GRASP THE CAGE WHEN DETACHING THE CAGE FROM IT. NO NARROWING OF THE INTERVERTEBRAL DISC WAS OBSERVED, AND THE CAGE WAS SEEMED TO BE INSERTED PARALLEL AGAINST THE INTERVERTEBRAL DISC. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147187 ↗
• MalfunctionMay 16, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS AS: LUMBAR SPINAL CANAL STENOSIS. FOR WHICH, PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION AT LEVELS: L2/3/4/5. INTRA-OP, WHEN INSERTING A CAGE INTO L2/3, IN ORDER TO AVOID RIBS, THE SURGEON TRIED TO RAISE THE CAGE SO AS TO BE RIGHT BESIDE THE INTERVERTEBRAL DISC WITH THE CAGE INSERTER FACING SLIGHTLY FROM THE CAUDAL SIDE TO THE CRANIAL SIDE. AS A RESULT, THE CAGE CRACKED FROM THE GROOVE NEXT TO THE INSERTER MOUNTING PART. THE CAGE BROKE IN ANTERIOR AND POSTERIOR PORTION. NEW CAGE WAS UNPACKED AND THE SURGEON USED OLIF CURVED INSERTER IN THE OPPOSITE DIRECTION AND THEN THE CAGE WAS INSERTED AT L2/3 WITHOUT ANY PROBLEM. NO FRAGMENT OF THE PRODUCT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568588 ↗
• MalfunctionMar 28, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS TYPE OF PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L2-5 IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON INSERTED THE CAGE USING THE INSERTER AND HAMMER, THE SCREW PART OF THE CAGE GOT SHAVED. THE INSERTER COULD NOT BE ATTACHED TO THE CAGE AGAIN. NO FRAGMENT OF THE BROKEN PRODUCT 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 6438401 ↗