GDLH® Posterior Spinal System 855-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00673978061825), received between Mar 29, 2018 and Mar 16, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REVISION SURGERY WAS HAPPENED ON 30TH OF MARCH. THE PATIENT IS OK. THE HOSPITAL REFUSED RETURN THE PRODUCT IN LOCAL RULES.

  Patient problems: Back pain

  MAUDE report 24603830 ↗
• InjuryMar 4, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING PHYSICAL LABOR IN THE GARDEN, THE PATIENT BENT DOWN AND EXPERIENCED A CRUNCH AND PAIN IN THE BACK. SUBSEQUENT FINDINGS INCLUDED A PARAVERTEBRAL CALCULUS ABSCESS AND AN EPIDURAL CALCULUS ABSCESS. INTERVENTIONS PERFORMED INCLUDED THORACOTOMY ON THE LEFT, DRAINAGE OF THE PARAVERTEBRAL CALCULUS ABSCESS, RESECTION OF TH10-TH12 VERTEBRAL BODIES, REMOVAL OF THE EPIDURAL CALCULUS ABSCESS, AND COMBINED INTERBODY FUSION (CORPORODESIS) FROM TH1 TO L1 USING MESH, AUTO-RIB, AND ALLOCITY. THE PATIENT HAD A SYMPTOM OF BACK PAIN. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE ROD FRACTURE HAPPENED AND THERE WAS A PLAN FOR REVISION SURGERY AT THE END OF(B)(6) 2026. ADDITIONAL INFORMATION RECEIVED THAT THE REVISION SURGERY HAD HAPPENED ON (B)(6) 2026.

  Patient problems: Back pain

  MAUDE report 24510534 ↗
• InjuryOct 15, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT TRANSPED ICULAR FIXATION OF THE SPINE AT THE L5 S1 LEVEL. IT WAS REPORTED THAT THE ROD BROKE POST OPERATIVELY AND PATIENT HAD BACK PAIN. REVISION SURGERY PERFORMED AND ROD WAS EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 20449167 ↗
• InjuryJul 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST REM OVAL OF A FOREIGN BODY FROM EXTRAMEDULLARY METAL STRUCTURES AND DISMANTLING OF AN IMMERSION FIXING SYSTEM. AFTER THAT DOCTOR DID TRANSPEDICULAR FIXATION OF THE SPINE WITH COMBINED METALLOSTEOSYNTHESIS OF TH11-12 - L4-5-S1 - PELVIC BONES. PATIENT WAS DIAGNOSED WITH TUBERCULOSIS OF BONES AND JOINTS. IT WAS REPORTED THAT THE ROD 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 19816781 ↗
• InjuryFeb 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A T H12-S1 INTERBODY FUSION PROCEDURE IN A PATIENT. PATIENT MEDICAL HISTORY: TUBERCULOSIS OF THE LUNGS. IT WAS REPORTED THAT THE IMPLANT BROKE. PATIENT IS HAVING BACK PAIN POST SURGERY. PRODUCT EXPLANT IS PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 18786784 ↗
• InjuryDec 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED IN A PATIENT POST A SCOLIOSIS CORRECTION PROCEDURE. IT WAS REPORTED THAT RODS BROKE TWICE IN THE PATIENT. THE RODS WERE EXPLANTED. 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 18361966 ↗
• InjuryJun 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH ROD. IT WAS REPORTED THAT ROD BROKE. ACCORDING TO THE PATIENT, THE INCIDENT OCCURRED AFTER FALLING AND CRUSHING WITH A LOAD OF 70 KG. PATIENT HAD BACKACHE AS A RESULT OF ROD BREAKAGE. REVISION SURGERY WILL BE PERFORMED TO EXPLANT THE BROKEN ROD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17180338 ↗
• InjuryMay 26, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE ROD BROKE AND THE PATIENT FEELS AN INCREASE IN BACK PAIN AND A CRUNCH IN THE CONSTRUCTION AREA FOR SIX MONTHS. ADDITIONAL SURGERY IS PLANNED TO EXPLANT THE ROD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17008556 ↗
• InjuryApr 12, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THE REVISION SURGERY WAS DONE ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 16722930 ↗
• InjuryMar 23, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH TUBERCULOSIS SPON DYLITIS AT TH9-10, L1 AND TRANSPEDICULAR FIXATION OF THE SPINE/OPEN METALLOSTEOSYNTHESIS AT TH 8-10, L1-4 FOR SPINAL THERAPY. THE PATIENT HAD BROAD DRUG RESISTANCE. IT WAS REPORTED THAT THE ROD WAS BROKEN POST OPERATIVELY. DON'T HAVE AN REOPERATION AT THE MOMENT. THERE WAS BACKACHE AS PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS AN ADDITIONAL SURGICAL OR MEDICAL INTERVENTION DONE OR PLANNED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT THE REOPERATION WAS PERFORMED ON (B)(6) 2021. CONCOMITANT DISEASES: TUBERCULOSIS STAGE 4B, PSYCHOACTIVE SUBSTANCES CHRONIC ADDICTION. THE MEDICAL DEVICE WAS UTILIZED AND NOT AVAILABLE FOR TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11549963 ↗
• InjuryNov 18, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A ROD DUE TO NON-SPECIFIC SPONDYLITIS TH9-L1, SPONDYLITIS STAGE, PEAK PHASE, PROGRESSION, INSTABILITY OF THE DORSAL SUBMERGED FIXING STRUCTURE. THE PROCEDURE INVOLVED WAS RADIOGRAPHY OF THE LOWER SECTION OF THE GOP AND POP. PATIENT'S MEDICAL HISTORY INCLUDES TRANSPEDICULAR FIXATION OF THE SPINE, OPEN COMBINED LAMINAR-PEDICULAR METALOSTEOSYNTHESIS TH4-6, TH9 ,TH11, L1-4. IT WAS REPORTED THAT THE ROD BROKE. THE IMPLANT DATE IS (B)(6) 2019. BROKEN FRAGMENTS REMAINED IN PATIENT. BACKACHE, FRACTURE OF THE METAL STRUCTURE AT THE L1 LEVEL WITH MIGRATION OF THE METAL STRUCTURE. SPINAL INSTABILITY AT THE LEVEL OF TH12, L1-3. FAILED POSTERIOR FUSION TH10, L5 WERE REPORTED AS A RESULT OF THE EVENT. THE ROD REMAINS IMPLANTED AND REVISION SURGERY WAS PLANNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10859431 ↗
• InjuryJul 30, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH (B)(6) PHASE OF THE PEAK, COMPLICATED BY PARAVERTEBRAL AND EPIDURAL FLOW ABSCESS AS PRE-OP DIAGNOSIS. THE PATIENT HAD MEDICAL HISTORY OF (B)(6) OF BONES AND JOINTS (B)(6). CHRONIC VIRAL (B)(6) OF MINIMAL ACTIVITY. THE DISEASE CAUSED BY (B)(6), MANIFESTATIONS OF MYCOBACTERIAL INFECTION (B)(6) INFECTION. IT WAS REPORTED THAT LEGACY ROD BROKE. THE ROD WAS IMPLANTED ON (B)(6) 2019. THE PRODUCT WILL NOT BE RETURNED AS IT IS IMPLANTED. PATIENT REPORTED PAIN AS A RESULT OF THE EVENT. REVISION SURGERY WILL BE CONDUCTED FOR EXPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 10343232 ↗
• InjuryJul 3, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH TUBERCULOUS SPONDYLITIS OF THE THORACIC AND LUMBAR SPINE FOR POLYSEGMENTAL LESIONS OF THE SPINE WITH APPLICATION OF IMPLANTS, STABILIZING SYSTEMS FOR THE PATIENT. IT WAS REPORTED THAT THE PRODUCT WAS BROKEN AFTER THE SURGERY. IT WAS A RECONSTRUCTIVE AND CORRECTIVE SURGERY FOR POLYSEGMENTAL LESIONS OF THE SPINE THE DEVICE WILL NOT RETURNED AND THERE WAS FRAGMENT LEFT INSIDE THE PATIENT. THERE WERE UNKNOWN PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10229116 ↗
• InjuryDec 2, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RECONSTRUCTIVE AND CORRECTIVE SURGERY FOR POLYSEGMENTAL LESION OF THE SPINE WITH APPLICATION OF IMPLANTS, STABILIZING SYSTEM FOR THE PATIENT DUE TO TUBERCULOUS SPONDILITIS. POST-OP, LEGACY ROD BROKE. THE MODEL OF PATIENT: POLYSEGMENTAL (4 OR MORE VERTEBRAE) AND SPECIFIC TUBERCULOUS OF THE THORACIC AND LUMBAR SPINE. THE PATIENT UNDERWENT REPLACEMENT OF TRANSPEDICULAR STABILIZATION SYSTEM AND SUFFERED FROM PAIN AS A RESULT OF THIS EVENT AS A RESULT OF ALLEGED EVENT.

  Patient problems: Pain

  MAUDE report 9393666 ↗
• InjuryOct 25, 2019Break; Break

  IT REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AND FIXATION DUE TO TRAUMA. ON AN UNKNOWN DATE, AFTER ABOUT 21 MONTHS POST-OP, IT WAS FOUND THAT THE IMPLANTED ROD HAD BROKEN. THE PATIENT DID NOT ACHIEVE SOLID FUSION DUE TO ROD BREAKAGE. THE PATIENT HAS NOT UNDERWENT ANY REVISION SURGERY YET AND IT IS UNKNOWN IF THERE WILL BE ANY REVISION SURGERY PERFORMED IN THE FUTURE.

  Patient problems: Failure of Implant

  MAUDE report 9236714 ↗
• MalfunctionMar 29, 2018Break; Break

  INITIAL DIAGNOSIS: SCOLIOSIS. IT WAS REPORTED VIA A PATIENT CALL THAT THE PATIENT UNDERWENT SURGERY IN 2013-14 IN WHICH A ROD WAS IMPLANTED. POST-OPERATIVELY, PATIENT SUFFERED FROM LUMBAR PAIN, PAIN IN WAIST AND DIFFICULTY TO SLEEP. AFTER EXAMINATION IT WAS OBSERVED THAT IMPLANTED ALLOY ROD WAS FOUND BROKEN.

  Patient problems: Pain; Sleep Dysfunction

  MAUDE report 7380564 ↗