CD HORIZON® Spinal System 7576545Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00885074031156), received between Feb 7, 2017 and Mar 11, 2026 — classified as 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A MAST TLIF/MAST SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LOW BACK PAIN, DISC HERNIATION AND DDD. IT WAS REPORTED THAT DURING THE  PROCEDURE, SURGEON USED LONGITUDE SYSTEM, AFTER PLACING THE SCREWS AND RODS, DURING THE FINAL TIGHTENING THE S1 SCREW GOT POPPED OUT. SURGEON REMOVED THE SCREW AND IMPLANTED ANOTHER MEDTRONIC SCREW. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COM PLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574644 ↗
• InjuryMay 19, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) - 2 LEVEL SPINAL THERAPY. LEVELS IMPLANTED AT L4-S1. IT WAS REPORTED THAT SCREWS WAS DISLOCATED AND IT REMAINS IN PATIENT. BROKEN SCREW SHAFT AND TULIP HEAD. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043860 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A SCREW USED IN MISS TLIF THERAPY. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ANTERIOR SLIPPAGE OF ABOUT 6MM DUE TO PARS FRACTURE. THE OPERATOR STARTED TO USE THE SCREW AFTER HE IMPLANTED WITH CAPSTONE 10*26. THE LEFT SIDE WAS ABOUT 4MM BACK AND THEN WHEN HE CHANGED SIDES, IT WAS FOUND THAT THE SCREW HEAD WAS SEPARATED FROM THE BODY OF THE SCREW. OPERATOR HAD IMPLANTED THE SCREW ON LEFT SIDE FIRST AND THEN THE RIGHT SIDE. THE LEFT SIDE WAS REPLACED WITH A NEW SCREW. THE DELAY WAS FOR ABOUT 40 MINUTES. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289850 ↗
• MalfunctionJan 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING MIS TLIF AT LEVEL L5-S1 FOR HIGH GRADE LISTHESIS. IT WAS REPORTED THAT THE CANNULATED SCREW BROKE INTRA OPERATIVELY. THERE WAS NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249224 ↗
• InjurySep 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WAS USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD REPORTED WITH BURST FRACTURE LAST WEEK AND WHEN X-RAY WAS DONE, ONE OF THE SCREW BROKE FROM THE SHAFT. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED DURING NORMAL USAGE OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181474 ↗
• MalfunctionJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN AN OLIF AT L5-S1 FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SCREW DISLOCATED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO M ANUFACTURING ISSUE WHEN THE BOX WAS OPENED (NORMAL, USABLE IMPLANT). NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545193 ↗
• MalfunctionApr 26, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, OTHER) REGARDING A PATIENT HAVING SPINAL THERAPY FOR L4-L5 DEGENERATIVE DISC AND FIXATION. IT WAS REPORTED THAT RIGHT SIDE WAS PATHOLOGY SIDE, L4,L5 ALL 4 GUIDEWIRES WERE PLACED. RIGHT SIDE DECOMPRESSION WAS DONE VIA METRX TUBE AND CAPSTONE CAGE PLACED. SCREWS AND SEXTANT ROD WERE PLACED ON RIGHT SIDE. LEFT SIDE SCREWS WERE PLACED, WHEN SURGEON MATED THE TOWERS, HE FELT ONE OF THE TOWERS WAS LOOSE , SO HE TOOK A SHOT TO FIND OUT THAT TOWER ALONG WITH TULIP OF SCREWS IS DISENGAGED FROM THE SCREW SHAFT THE SCREW SHAFT WAS IN L5 BODY ON LEFT SIDE HE REMOVED THE TOWER, WITH HELP OF GUIDEWIRE AND REMOVAL DRIVER REMOVED THE SCREW SHAFT FROM L5 BODY IT WAS REPLACED WITH NEW SCREW, TOWERS WERE MATED AND SEXTANT ROD WAS INSERTED, BOP'S PLACED AND BREAK OFF DONE.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FORM MANUFACTURER THAT SCREW SHAFT BROKEN FROM ITS TULIP DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19189003 ↗
• InjuryJan 16, 2024Break; Break

  DURING THE REVISION PROCEDURE, THE POST-OP DISLODGED SCREW WITH SIZE 6.5X45MM WAS REMOVED AND REPLACED WITH A LARGER SCREW (SIZE 7.5X50MM SEXTANT SCREW). ADDITIONALLY, ANOTHER CAPSTONE CAGE WITH SIZE 10X22MM CAPSTONE WAS PLACED SUCCESSFULLY TO CONVERT THE TLIF WITH 10X22MM CAPSTONE TO PLIF. HOWEVER, WHILE USING THE SEXTANT REDUCTION INSTRUMENTS AT THE LEFT L5 PEDICLE SCREW TO REDUCE THE LISTHESIS, DOCTOR FELT THE INSTRUMENT TIGHTENING SUDDENLY GONE LOOSE. UPON INSPECTION, HE FOUND OUT THAT THE HEAD OF THE SCREW WAS STILL IN THE INSTRUMENT, WHILE THE SCREW SHAFT WAS INTACT IN THE VERTEBRAL BODY SAME SIZE AS THE FIRST DISLODGE SCREW 6.5X45MM SEXTANT SCREW, DOCTOR REPLACED THE 2ND DISLODGE SCREW WITH A LARGER 7.5X50MM SEXTANT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 18515645 ↗
• InjuryJan 16, 2024Break; Break

  DURING THE REVISION PROCEDURE, THE POST-OP DISLODGED SCREW WITH SIZE 6.5X45MM WAS REMOVED AND REPLACED WITH A LARGER SCREW (SIZE 7.5X50MM SEXTANT SCREW). ADDITIONALLY, ANOTHER CAPSTONE CAGE WITH SIZE 10X22MM CAPSTONE WAS PLACED SUCCESSFULLY TO CONVERT THE TLIF WITH 10X22MM CAPSTONE TO PLIF. HOWEVER, WHILE USING THE SEXTANT REDUCTION INSTRUMENTS AT THE LEFT L5 PEDICLE SCREW TO REDUCE THE LISTHESIS, DOCTOR FELT THE INSTRUMENT TIGHTENING SUDDENLY GONE LOOSE. UPON INSPECTION, HE FOUND OUT THAT THE HEAD OF THE SCREW WAS STILL IN THE INSTRUMENT, WHILE THE SCREW SHAFT WAS INTACT IN THE VERTEBRAL BODY SAME SIZE AS THE FIRST DISLODGE SCREW 6.5X45MM SEXTANT SCREW, DOCTOR REPLACED THE 2ND DISLODGE SCREW WITH A LARGER 7.5X50MM SEXTANT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 18515643 ↗
• InjuryOct 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVEL L4-5 FOR LOW BACK PAIN WITH SEVERE CLAUDICATION SYMPTOMS AND L4-5 GRADE1 LISTHESIS WITH SIGNIFICANT STENOSIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN POST OPERATIVELY. REVISION SURGERY WAS PERFORMED AND TOTAL CONSTRUCT WAS REPLACED WITH NEW SCREWS. PATIENT STARTED TO HAVE SEVERE LOW BACK PAIN WHICH WAS GRADUALLY PROGRESSIVE, LEADING TO RADICULAR SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17982463 ↗
• InjuryOct 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVEL L4-5 FOR LOW BACK PAIN WITH SEVERE CLAUDICATION SYMPTOMS AND L4-5 GRADE1 LISTHESIS WITH SIGNIFICANT STENOSIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN POST OPERATIVELY. REVISION SURGERY WAS PERFORMED AND TOTAL CONSTRUCT WAS REPLACED WITH NEW SCREWS. PATIENT STARTED TO HAVE SEVERE LOW BACK PAIN WHICH WAS GRADUALLY PROGRESSIVE, LEADING TO RADICULAR SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17982459 ↗
• InjuryJul 24, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Pain

  MAUDE report 17386520 ↗
• MalfunctionSep 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WH ICH OCCURRED DURING AE L5-S1 MIS-TLIF SURGERY IN A PATIENT DIAGNOSED WITH L5-S1 HIVD, GRADE I SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING THE LAST STEP TO LOOSEN OUTER AND INNER EXTENDER, WHEN HCP TRIED TO REMOVE THE EXTENDER, HE FOUND A LITTLE TIGHT. HCP MADE SMALL FORCE ON EXTENDER AND SCREW HEAD AND THREAD WAS SEPARATED. THE SURGEON UNSCREWED THE SCREW AND REPLACED WITH THE NEW SCREW, IT SUCCEEDED TO BE BROKEN OFF AND COMPLETE THE SURGERY. 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 15388878 ↗
• InjuryMay 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A TLIF PROCEDURE. IT WAS REPORTED THAT THE SCREW BROKE AND DISASSEMBLED FROM HEAD TO SHAFT. ONE WEEK AFTER SURGERY, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14334245 ↗
• InjuryFeb 18, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A DISTRIBUTOR REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN AN L5 TPS SCREW DISLODGE AND LAMINECTOMY AND REVISE L5 SCREW FOR A 2ND DEGREE SPONDYLOLISTHESIS OF L5 AND S1 AT L5 RIGHT SIDE. IT WAS REPORTED THAT USING MEDTRONIC SEXTANT PRODUCTS, IMPLANTED STEEL NAILS, AND ROD REDUCTION, THE RADIOGRAPHIC IMAGES FROM THE OPERATION FOUND THAT THE SCREW NAIL HEAD AND THE NAIL BODY OF THE IMPLANTED PRODUCT WERE SEPARATED. THE DAMAGED NAILS WERE TAKEN OUT AND REPLACED WITH NEW ONES. THE SCREW BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE PATIENT WAS UNCOMFORTABLE AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT WAS (B)(6) 2022 AND DATE OF EXPLANT WAS (B)(6)2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Discomfort

  MAUDE report 13556719 ↗
• InjuryJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SCREW USING ALIF & PPF. PRE-OPERATIVE DIAGNOSIS FOR INITIAL SURGERY WAS STENOSIS . IT WAS REPORTED THAT POST-OP,¿SCREW HEAD FULL OUT (SEPARATED). IN THE REVISION SURGERY¿REMOVED FULL OUT SCREW, AND IMPLANTED LARGER SIZE SCREW.¿PATIENT HAD TO TAKE REVISION SURGERY, AGAIN INCISION, LARGER SIZE OF SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918920 ↗
• InjuryMar 23, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH REVISION OF THE SURGERY TO REMOVE OLD SCREWS OUT FOR LONGITUDE I SPINAL THERAPY. IT WAS REPORTED THAT THE HALF-THREADED TULIP SCREW BROKE, THE LOWER PART OF THE SCREW THREAD REMAINED IN THE PATIENT. FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11549741 ↗
• InjuryMar 23, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH REVISION OF THE SURGERY TO REMOVE OLD SCREWS OUT FOR LONGITUDE I SPINAL THERAPY. IT WAS REPORTED THAT THE HALF-THREADED TULIP SCREW BROKE, THE LOWER PART OF THE SCREW THREAD REMAINED IN THE PATIENT. FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11549696 ↗
• InjuryJul 1, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH DEFORMITY FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS: GENDER- MALE, DATE OF IMPLANT: UNKNOWN DATE, DATE OF EXPLANT: (B)(6) 2020, DEVICE RETURN STATUS: PARTIALLY EXPLANTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREW HEAD OF IMPLANTED PRODUCT WAS BROKEN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO REMOVE THE BROKEN SCREW AND REPLACED WITH ANOTHER SIZE OF SCREW. IT WAS PARTIAL EXPLANT. ONLY SCREW HEAD COULD BE EX-PLANTED AND THREADED PORTION WAS STILL INSIDE THE PATIENT. UPDATE RECEIVED ON 21 JUN 2020: PATIENT DEMOGRAPHICS: WEIGHT- (B)(6) KG, PROCEDURE INVOLVED: PERCUTANEOUS. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT. THERE WAS NO PLAN TO REMOVE THE THREADED PORTION OF THE SCREW FROM PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216544 ↗
• InjuryApr 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BACK PAIN; AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE HEAD AND THE BODY OF THE SCREW GOT SEPARATED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10001327 ↗
• InjuryFeb 4, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND MINIMALLY INVASIVE PERCUTANEOUS PEDICLE SCREW FIXATION (MIS-PPF) AT ONE LEVEL. AFTER ONE DAY, POST-OP, THE IMPLANTED SCREW BROKE. THE HEAD OF THE SCREW GOT SEPARATED FROM THE BODY. THE PATIENT ALSO REPORTED BACK PAIN. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE IMPLANTS WERE COMPLETELY EXPLANTED; AND WERE REPLACED WITH PRODUCTS MANUFACTURED BY ANOTHER MANUFACTURER. THE PATIENT IS RECOVERING AFTER THE REVISION SURGERY. NO OTHER ISSUES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 9666623 ↗
• InjurySep 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. POST-OPERATIVELY, THE HEAD OF THE SCREW SEPERATED FROM THE SCREW BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7859014 ↗
• InjuryDec 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  TYPE OF PROCEDURE IN THE INITIAL SURGERY: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THE PATIENT UNDERWENT REVISION SURGERY FOR REPLACING THE DEFECTED SCREW WITH A NEW THICKER ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141465 ↗
• InjuryJul 10, 2017Detachment Of Device Component; Detachment Of Device Component

  THE SCREW DETACHED FROM SCREW HEAD WHILE REMOVAL. NO NERVE ISSUES WERE OBSERVED ON OPERATED LEVEL.

  Patient problems: No Code Available; Pain

  MAUDE report 6696353 ↗
• InjuryFeb 7, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2015 (DATE UNKNOWN): PATIENT UNDERWENT SURGERY. PATIENT HAD CHRONIC PAIN FOR 06 MONTHS. ON (B)(6) 2015 (DATE UNKNOWN): PATIENT VISITED HER DOCTOR DUE TO PAIN. ON (B)(6) 2016 (DATE UNKNOWN): PATIENT UNDERWENT MRI WHICH SHOWED TWO BROKEN SCREWS. ON (B)(6) 2016 (DATE UNKNOWN): PATIENT UNDERWENT SECOND SURGERY WHERE PATIENT WAS INTERVENED AND THE PRODUCT WAS CHANGED.

  Patient problems: No Code Available; Pain

  MAUDE report 6306300 ↗