CLYDESDALE PTC™ Spinal System 4986850Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169190528), received between Dec 29, 2016 and Nov 4, 2024 — classified as 3 injuries, 20 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LATERAL LUMBAR INTERBODY FUSION THERAPY FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE CAGE BROKE WHILE INSERTING THE CAGE INTO THE BODY WHILE HITTING THE INSERTER WITH A HAMMER. ALL WERE REMOVED AND REPLACED WITH A NEW PRODUCT. IMPLANT WAS IMPLANTED AND EXPLANTED ON BOTH 10/9. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT IS HCV+, SO THE CUSTOMER REQUESTED DISPOSAL. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL 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 20599020 ↗
• MalfunctionOct 8, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF OBLIQUE LATERAL INTERBODY FUSION THERAPY FOR DECOMPRESSION SURGERY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED AT L4-5 IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED, THE CONNECTION BETWEEN THE NAVI INSERTER AND THE CAGE CAME OFF. AT THAT TIME, THE PART THAT WAS IN CONTACT WITH THE INSERTER WAS DAMAGED. IT BECAME DIFFICULT TO REMOVE THE DEVICE, SO IT WAS DECIDED TO PUSH THE CAGE AND THE INSTALLATION WAS COMPLETED, SO THE OLIF WAS COMPLETED. THERE WAS LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE EVENT HAPPENED DURING NORMAL USAGE OF DEVICE AND NOT A MANUFACTURING ISSUE. THERE IS NO ADDITIONAL SURGERY PLANNED OR SCHEDULED TO REMOVE THE IMPLANTED CAGE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION/ALLEGATION ASSOCIATED WITH THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397375 ↗
• MalfunctionDec 27, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR UNKNOWN INDICATION. IT WAS REPORTED THAT IMPLANT FRACTURED. THERE WAS TIGHT DISC SPACE WITH SCLEROTIC OSTEOPHYTES, UPON IMPACTION OF THE INSERTER THE IMPLANT BROKE. 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 13086738 ↗
• MalfunctionDec 27, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR UNKNOWN INDICATION. IT WAS REPORTED THAT IMPLANT FRACTURED. THERE WAS TIGHT DISC SPACE WITH SCLEROTIC OSTEOPHYTES, UPON IMPACTION OF THE INSERTER THE IMPLANT BROKE. 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 13086692 ↗
• MalfunctionNov 25, 2021Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-L5 OLIF. THE PRE-OP DIAGNOSIS WAS MENTIONED AS "DEGENERATIVE LUMBAR SCOLIOSIS". IT WAS REPORTED THAT, IN THE CASE OF L2-5 OLIF, AFTER THE OLIF WAS PERFORMED AT L4 / 5 AND L3 / 4, THE CAGE DID NOT ENTER AT ALL FROM THE MIDDLE DURING THE OLIF OF L2 / 3. THE CAGE COULD NO LONGER BE TAPPED AND INSERTED, AND THE INSERTER COULD NOT BE ATTACHED BECAUSE THE THREAD PART OF THE CAGE WAS BROKEN. THEY USED A REMOVER, BUT THE CAGE DID NOT MOVE AT ALL.  FINALLY THEY GRABBED THE CAGE WITH LUER AND MANAGED TO REMOVE IT. THEY REPLACED IT WITH A NEW CAGE, BUT THE SECOND CAGE HAD THE SAME EVENT AND WAS REMOVED BY THE SAME MEANS. THERE WAS A DELAY OF MORE THAN 60 MINUTES REPORTED AS A RESULT. NO FRAGMENTS OF BROKEN CAGES REMAINED IN PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874352 ↗
• MalfunctionNov 25, 2021Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-L5 OLIF. THE PRE-OP DIAGNOSIS WAS MENTIONED AS "DEGENERATIVE LUMBAR SCOLIOSIS". IT WAS REPORTED THAT, IN THE CASE OF L2-5 OLIF, AFTER THE OLIF WAS PERFORMED AT L4 / 5 AND L3 / 4, THE CAGE DID NOT ENTER AT ALL FROM THE MIDDLE DURING THE OLIF OF L2 / 3. THE CAGE COULD NO LONGER BE TAPPED AND INSERTED, AND THE INSERTER COULD NOT BE ATTACHED BECAUSE THE THREAD PART OF THE CAGE WAS BROKEN. THEY USED A REMOVER, BUT THE CAGE DID NOT MOVE AT ALL. FINALLY THEY GRABBED THE CAGE WITH LUER AND MANAGED TO REMOVE IT. THEY REPLACED IT WITH A NEW CAGE, BUT THE SECOND CAGE HAD THE SAME EVENT AND WAS REMOVED BY THE SAME MEANS. NO FRAGMENTS OF BROKEN CAGES REMAINED IN PATIENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES REPORTED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874325 ↗
• MalfunctionApr 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH SPINAL CANAL STENOSIS SUGGESTED FOR OLIF. LEVELS IMPLANTED L4/5. IT WAS REPORTED THAT THE PRODUCT CAME OFF THE THREAD DURING INSERTION, THE PRODUCT COULDN'T BE RECONNECT BECAUSE IT WAS ALREADY BROKEN. THE PRODUCT WAS REMOVED ONCE AND REPLACED AND THE PROCEDURE WAS PERFORMED. NO DEVICE FRAGMENT LEFT IN PATIENT. NO PATIENT SYMPTOM OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED. THE INSERTER CAME OFF WHILE INSERTING THE CAGE. THEY COULDN'T BE RECONNECT BECAUSE THE SCREW THREAD WAS BROKEN. THEREFORE, A NEW CAGE WAS OPENED AND USED. THE NEW CAGE WAS ABLE TO BE INSERTED WITH THE SAME INSERTER. BEFORE INSERTING THE FIRST CAGE, DISTRACTOR UP TO 10MM HAD BEEN USED. THERE WAS NO INTERFERENCE WITH THE ILIUM OF THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647526 ↗
• MalfunctionMay 1, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, WHEN THE CAGE WAS BEING INSERTED WITH INSERTER, AND WHEN CHECKING THE SAGITTAL IMAGE, THE CAGE WAS FOUND TO HAVE COME-OFF THE INSERTER. AT THAT TIME, IT WAS NOTICED THAT A PART OF THE GRIP OF THE CAGE AND THE THREAD WAS BROKEN. THE CAGE COULD NOT BE REMOVED BY THE REMOVER; SO, THE LOWER HALF OF THE L4 VERTEBRAL BODY WAS SHAVED AND PULLED OUT WITH HERNIA FORCEPS. AFTER THAT, THE CAGE WAS REPLACED WITH A BIGGER CAGE OF SIZE 22MM-12 DEGREES-10MM X 50MM; AND IT WAS INSERTED TO L4-L5. THIS CAGE WAS NOTICED TO BE A GOOD POSITION, AFTER WHICH, WOUND CLOSURE WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. IT WAS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10017736 ↗
• MalfunctionFeb 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) SURGERY AT L3/4 DUE TO DEGENERATIVE KYPHOSCOLIOSIS. INTRA-OP, AFTER PLACING THE CAGE USING AN INSERTER, THE IMAGE WAS CHECKED AND IT WAS DETERMINED THAT CAGE POSITION ADJUSTMENT WAS NECESSARY. THE EDGE OF THE CAGE BROKE WHEN SURGEON HIT THE CAGE BY THE TRAIL TO MAKE THE ADJUSTMENTS. IT WAS JUDGED BY THE SURGEON THAT JUST THE SURFACE WAS CHIPPED AND THE PLACING POSITION HAD NO PROBLEM, AND THE RISK OF REPLACING THE IMPLANT WAS HIGH, THEREFORE, IMPLANT REPLACEMENT WAS NOT PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT WITHOUT ANY DELAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9669731 ↗
• MalfunctionOct 11, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5 DUE TO SPINAL CANAL STENOSIS. THE PROCEDURE WAS PERFORMED IN RIGHT DECUBITUS POSITION APPROACHING FROM THE LEFT SIDE. THERE WAS SCOLIOSIS AND THE APPROACHING SIDE WAS NARROW. INTRA-OP, DURING CAGE INSERTION WITH THE INSERTER, THE CAGE ADVANCED WHEN THE SURGEON WAS TRYING TO REMOVE THE SLEEVE USING A SLEEVE REMOVER. REPORTEDLY, THE SLEEVE WAS REMOVED EARLY. THE PLACE WHERE THE CAGE WAS INSERTED A LITTLE HAD BECOME NARROWED. AT THAT MOMENT, THE SLEEVE DID NOT COME OUT AND ONLY THE CAGE ADVANCED. WHEN HITTING THE HANDLE OF THE SLEEVE REMOVER IN ORDER TO REMOVE THE CAGE, THE CAGE WAS DETACHED FROM THE INSERTER. WHEN THE SURGEON REMOVED THE CAGE, THE THREAD OF THE REMOVED CAGE BROKE. HENCE, A NEW CAGE WAS OPENED AND INSERTED SUCCESSFULLY USING THE SAME INSERTER. ACCORDING TO THE SALES REP, THE INSERTER AND THE CAGE MIGHT HAVE DEVIATED WHEN THE HANDLE OF THE SLEEVE REMOVER WAS HIT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO FRAGMENT OF THE BROKEN CAGE REMAINED INSIDE THE PATIENT; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178863 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION OF 3 INTERVERTEBRAL DISCS DUE TO LUMBAR KYPHOSIS. INTRA-OP, WHEN THE CAGE WAS BEING INSERTED AT L4-L5, IT BROKE INTO TWO PIECES. IT WAS A CASE THAT THE ORIGINAL VERTEBRAL DISC HEIGHT WAS NEARLY ZERO. WHEN THE CAGE WAS INSERTED TO SOME EXTENT, THE CAGE TOUCHED THE CONTRALATERAL OSTEOPHYTE AND DID NOT ADVANCE. WHEN THE CAGE WAS HAMMERED STRONGLY WITH A PLASTIC HAMMER, AND WHEN THE FRONTAL IMAGES WERE CHECKED, IT WAS FOUND THAT THE OSTEOPHYTE BROKE. THE CAGE WAS ALSO SUSPECTED TO BE BROKEN BECAUSE THE CAGE POSITION WAS FOUND STRANGE WHEN CHECKING THE IMAGES AFTER THE CAGE WAS INSERTED. THE CAGE COULD NOT BE REMOVED AND WAS IMPLANTED AS IT WAS. WOUND CLOSURE WAS PERFORMED. THERE WAS A DELAY OF ABOUT 3 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8585384 ↗
• MalfunctionApr 18, 2019Break; Break

  PREOPERATIVE DIAGNOSIS: LCS(LUMBAR CANAL STENOSIS) PROCEDURE: OLIF (OBLIQUE LUMBAR INTERBODY FUSION) LEVELS IMPLANTED: L3/4 IT WAS REPORTED THAT, INTRA-OP, THE POSTERIOR SIDE 1/3 OF THE CAGE WAS BROKEN DURING CAGE INSERTION. THE CAGE WAS JUDGED DIFFICULT TO BE REMOVED, AND 2/3RD PART INDWELT. IT IS UNKNOWN WHETHER ANY PATIENT COMPLICATIONS OCCURRED AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525894 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L2-L5 DUE TO AUTONOMIC DYSREFLEXIA (ADS). INTRA-OP, CAGE WAS BROKEN WHILE INSERTION IN THE PATIENT'S BODY. WHEN INSERTED THE FIRST CAGE AT L3/4, THE CAGE WAS PLACED TOWARD POSTERIOR SIDE. THE PHYSICIAN ATTEMPTED TO CORRECT THE DIRECTION USING EXTRACTOR BUT FAILED. SINCE THERE WAS A POSSIBILITY THAT THE NERVE ROOT ON OPPOSITE WAS BEING COMPRESSED, THE PHYSICIAN EXPANDED THE POSTERIOR SIDE AND CHECKED WITH MICROSCOPE, THEN THE END OF THE CAGE WAS FOUND. WHEN HAMMERING THE VISIBLE PART WITH BONE TAMP, PART OF THE CAGE WAS BROKEN AND CAME OUT. THE PART OF BROKEN PIECES CAME OUT. THE BROKEN PIECES WERE DISCARDED IN THE HOSPITAL. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO INFORMATION REGARDING PATIENT IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454807 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL CANAL STENOSIS AND UNDERWENT ANTERIOR LUMBAR FUSION AT L2/3. DURING SURGERY, OBLIQUE LUMBAR INTERBODY FUSION WAS PERFORMED UNTIL TH12/L3. WHEN CLOSING THE WOUND, THE CAGE WHICH WAS INSERTED AT L2/3 DEVIATED TO THE VENTRAL SIDE AND THE ANTERIOR LONGITUDINAL LIGAMENT WAS INJURED. FOR RECOVERY, IT WAS ATTEMPTED TO INSERT THE CAGE TO DORSAL SIDE. SO THE PRODUCT WAS TRIED TO BE INSERTED AGAIN IN ANOTHER DIRECTION, BUT THE DIRECTION COULD NOT FIT WELL. HENCE CAGE INSERTION WAS GIVEN UP AND THE CAGE WAS REPLACED WITH AUTOGENOUS BONE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. PRODUCT CAME IN CONTACT WITH PATIENT. PARALYSIS OCCURRED TO PATIENT.

  Patient problems: Injury; Paralysis

  MAUDE report 7900059 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL CANAL STENOSIS AND UNDERWENT ANTERIOR LUMBAR FUSION AT L2/3. DURING SURGERY, OBLIQUE LUMBAR INTERBODY FUSION WAS PERFORMED UNTIL TH12/L3. WHEN CLOSING THE WOUND, THE CAGE WHICH WAS INSERTED AT L2/3 DEVIATED TO THE VENTRAL SIDE AND THE ANTERIOR LONGITUDINAL LIGAMENT WAS INJURED. FOR RECOVERY, IT WAS ATTEMPTED TO INSERT THE CAGE TO DORSAL SIDE. SO THE PRODUCT WAS TRIED TO BE INSERTED AGAIN IN ANOTHER DIRECTION, BUT THE DIRECTION COULD NOT FIT WELL. HENCE CAGE INSERTION WAS GIVEN UP AND THE CAGE WAS REPLACED WITH AUTOGENOUS BONE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. PRODUCT CAME IN CONTACT WITH PATIENT. PARALYSIS OCCURRED TO PATIENT.

  Patient problems: Injury; Paralysis

  MAUDE report 7900045 ↗
• MalfunctionJul 31, 2018Break; Material Separation

  PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LCS. INTRA-OP, WHEN INSERTING THE CAGE WITH INSERTER, THE POSTERIOR PART OF THE CAGE WAS BROKEN AND SEPARATED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ABOUT 1/5 OF THE REPORTED PRODUCT WAS BROKEN ON THE SIDE WHERE IT WAS ATTACHED TO THE INSERTER. ABOUT 4/5 WAS PLACED BY THE JUDGEMENT OF THE DOCTOR. THE FRAGMENT OF THE CAGE BROKEN INTRA-OPERATIVELY WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7737216 ↗
• MalfunctionJul 31, 2018Break; Difficult to Insert

  IT WAS REPORTED THAT INTRA-OPERATIVELY THE CAGE WAS BROKEN WHILE INSERTION. THE IMPACTOR PART OF THE CAGE WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED AND THE BROKEN CAGE WAS REPLACED WITH THE NEW DEVICE DUE TO WHICH PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTE. THE CAGE WAS INSERTED OBLIQUELY TO THE CRANIAL SIDE. DIRECTION OF CAGE WAS CHANGED AND PROCEDURE WAS COMPLETED WITH THE NEW CAGE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734343 ↗
• MalfunctionJun 29, 2018Break; Break

  TYPE OF PROCEDURE OR TECHNIQUE USED : LUMBAR ANTEROPOSTERIOR FUSION LEVELS IMPLANTED: L3/4/5 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS, SPINAL CANAL STENOSIS. INTRA-OP, THE CAGE WAS BROKEN WHEN GRIPPING THE HIGH PART OF CAGE TO REMOVE IT WITH SLAP HAMMER. THE CAGE COULD NOT BE REMOVED ANY MORE. DD WAS INDWELT IN THE POSITION AND THE OPERATION WAS COMPLETED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HALF OF THE IMPLANT WAS LEFT IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650010 ↗
• MalfunctionSep 5, 2017Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS AT LEVEL L4-5. INTRA OP, CAGE USING A SLEEVE INSERTER BROKE. ALTHOUGH THE HEIGHT OF INTERVERTEBRAL DISC WAS NOT PARTICULARLY NARROW, STILL CAGE COULD NOT BE INSERTED AT ALL. THE SLEEVE OF THE INSERTER THAT WAS PLACED INTO THE OPPOSITE SIDE OF THE BODY JUST ROSE UP TO THE NEAR SIDE (LEFT SIDE) AND THE CAGE COULD NOT BE INSERTED. AS A RESULT, THE SCREW THREAD OF THE CAGE FOR ENGAGING WITH INSERTER WAS BROKEN AND IT BECAME USELESS. REMOVAL OF INTERVERTEBRAL DISC WAS CONDUCTED AGAIN AND NEW CAGE WAS USED TO INSERT BUT SAME EVENT HAPPENED. THEY COULDN¿T BE INSERTED FORWARD FROM ENTRANCE OF THE VERTEBRA, AND SCREW-THREADS OF THOSE CAGES WERE BROKEN DURING HAMMERING. THE SLEEVE OF INSERTER WAS INSERTED TO TWO-THIRD DEPTH OF INTERVERTEBRAL SPACE. CAGES IN THE SAME SIZE RUN OUT, SO 8×55 MM CAGE WAS USED INSTEAD. IT IS CONSIDERED THAT AS THE POSITION OF THE TRIAL WAS LOCATED SLIGHTLY THE REAR OF THE INTERVERTEBRAL DISC, THE CAGE WAS TRIED TO BE INSERTED FORWARD, SO EVEN THOUGH THE SLEEVE COULD BE ENTERED IN THE INTERVERTEBRAL DISC, THE PART OF THE CAGE PROTRUDING FROM THE SLEEVE TOU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6841145 ↗
• MalfunctionSep 5, 2017Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS AT LEVEL L4-5. INTRA OP, CAGE USING A SLEEVE INSERTER BROKE. ALTHOUGH THE HEIGHT OF INTERVERTEBRAL DISC WAS NOT PARTICULARLY NARROW, STILL CAGE COULD NOT BE INSERTED AT ALL. THE SLEEVE OF THE INSERTER THAT WAS PLACED INTO THE OPPOSITE SIDE OF THE BODY JUST ROSE UP TO THE NEAR SIDE (LEFT SIDE) AND THE CAGE COULD NOT BE INSERTED. AS A RESULT, THE SCREW THREAD OF THE CAGE FOR ENGAGING WITH INSERTER WAS BROKEN AND IT BECAME USELESS. REMOVAL OF INTERVERTEBRAL DISC WAS CONDUCTED AGAIN AND NEW CAGE WAS USED TO INSERT BUT SAME EVENT HAPPENED. THEY COULDN¿T BE INSERTED FORWARD FROM ENTRANCE OF THE VERTEBRA, AND SCREW-THREADS OF THOSE CAGES WERE BROKEN DURING HAMMERING. THE SLEEVE OF INSERTER WAS INSERTED TO TWO-THIRD DEPTH OF INTERVERTEBRAL SPACE. CAGES IN THE SAME SIZE RUN OUT, SO 8×55 MM CAGE WAS USED INSTEAD. IT IS CONSIDERED THAT AS THE POSITION OF THE TRIAL WAS LOCATED SLIGHTLY THE REAR OF THE INTERVERTEBRAL DISC, THE CAGE WAS TRIED TO BE INSERTED FORWARD, SO EVEN THOUGH THE SLEEVE COULD BE ENTERED IN THE INTERVERTEBRAL DISC, THE PART OF THE CAGE PROTRUDING FROM THE SLEEVE TOU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6841143 ↗
• MalfunctionSep 4, 2017Break; Break

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¿S MARKER WAS WRONG BY SAGITTAL IMAGE, SO HE TOLD TO THE SURGEON TO STOP THE PROCEDURE AND CONFIRM, THEN THE CAGE WAS FOUND TO BE BROKEN. THE HOLDER WAS PULLED OUT FROM THE SURGICAL FIELD TOGETHER WITH THE CAGE BROKEN AT THE POINT OF THE 1/3 FROM THE GRIPPED PART. THE REMAINING CAGE WAS TRIE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840872 ↗
• MalfunctionFeb 10, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: OLIF SURGERY WAS SCHEDULED AT L2/3/4/5 FOR KYPHOSIS PROCEDURE: L2/3/4: OBLIQUE LUMBAR INTERBODY FUSION (ONLY ANTERIOR FUSION) LEVELS IMPLANTED: L2/3/4 IT WAS REPORTED THAT THE CAGE WAS HARD TO INSERT AS THE INTERVERTEBRAL AREA WAS NARROW AND HENCE BROKE DURING SURGERY. AFTER CAGE WAS REMOVED ONCE, REINSERTION WAS PERFORMED WITH ANOTHER CAGE AND THE SURGERY WAS FINISHED WITHOUT PROBLEMS. NO FRAGMENTS 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 6321250 ↗
• InjuryDec 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OP DIAGNOSIS: STENOSIS AT L3-S PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION IT WAS REPORTED THAT POST-OP, GENERAL SYMPTOM (FEVER ETC.) WAS OBSERVED DUE TO INFECTION AROUND THE IMPLANTED DEVICE. AFTER THE EVENT, REVISION SURGERY WAS PERFORMED TO CLEAN AND PLACE A DRAIN FROM ANTERIOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6212036 ↗