CD HORIZON Fenestrated Screw SetRecalls & reported problems across all models

We found 27 models of CD HORIZON Fenestrated Screw Set by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2020 and Sep 28, 2026 — classified as 33 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CD HORIZON Fenestrated Screw Set problems

CD HORIZON Fenestrated Screw Set models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CD HORIZON® Fenestrated Screw Set 55750026545

  Thoracolumbosacral pedicle screw system
  10 reports
• CD HORIZON® Fenestrated Screw Set 55750026540

  Thoracolumbosacral pedicle screw system
  8 reports
• CD HORIZON® Fenestrated Screw Set 55750025540

  CEMENT, BONE, VERTEBROPLASTY
  7 reports
• CD HORIZON® Fenestrated Screw Set 55750027540

  Thoracolumbosacral pedicle screw system
  6 reports
• CD HORIZON® Fenestrated Screw Set 55750026550

  CEMENT, BONE, VERTEBROPLASTY
  5 reports
• CD HORIZON® Fenestrated Screw Set 55850026540

  Orthosis, spinal pedicle fixation
  2 reports
• CD HORIZON® Fenestrated Screw Set 55850027540

  Orthosis, spinal pedicle fixation
  2 reports
• CD HORIZON® Fenestrated Screw Set 55750027545

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• CD HORIZON® Fenestrated Screw Set 55750027555

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• CD HORIZON® Fenestrated Screw Set 55750025535

  Thoracolumbosacral pedicle screw system
  2 reports
• CD HORIZON® Fenestrated Screw Set 55750025550

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• CD HORIZON® Fenestrated Screw Set 55751026545

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• CD HORIZON® Fenestrated Screw Set 55840025545T

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• CD HORIZON® Fenestrated Screw Set 55840027545T

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• CD HORIZON® Fenestrated Screw Set 55840027550T

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• CD HORIZON® Fenestrated Screw Set 7480741T

  SCREWDRIVER
  1 report
• CD HORIZON® Fenestrated Screw Set 55851025545

  Thoracolumbosacral pedicle screw system
  1 report
• CD HORIZON® Fenestrated Screw Set 55851025550

  CEMENT, BONE, VERTEBROPLASTY
  1 report
• CD HORIZON® Fenestrated Screw Set 55750027535

  Thoracolumbosacral pedicle screw system
  1 report
• CD HORIZON® Fenestrated Screw Set 55750027550

  Thoracolumbosacral pedicle screw system
  1 report
• CD HORIZON® Fenestrated Screw Set 55750024535

  CEMENT, BONE, VERTEBROPLASTY
  1 report
• CD HORIZON® Fenestrated Screw Set 55750025545

  CEMENT, BONE, VERTEBROPLASTY
  1 report
• CD HORIZON® Fenestrated Screw Set 55751025540

  CEMENT, BONE, VERTEBROPLASTY
  1 report
• CD HORIZON® Fenestrated Screw Set 55751025545

  Thoracolumbosacral pedicle screw system
  1 report
• CD HORIZON® Fenestrated Screw Set 55751025550

  CEMENT, BONE, VERTEBROPLASTY
  1 report
• CD HORIZON® Fenestrated Screw Set 55751027545

  Thoracolumbosacral pedicle screw system
  1 report
• CD HORIZON® Fenestrated Screw Set 55751027550

  Thoracolumbosacral pedicle screw system
  1 report

Recent CD HORIZON Fenestrated Screw Set adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Leak/Splash

  Information was received from the Health care professional via a manufacturer representative regarding a device used for L2-5 Lateral Lumbar Interbody Fusion, L2-L5 ercutaneous pedicle screw fixation, L2, L4, L5 Femoral Neck System procedures.The preoperative diagnosis for this surgery was L2/3/4/5 lumbar spinal canal stenosis with degenerative scoliosis.It was reported that during intra-op,when filling the cement, it felt harder than usual. During cement insertion on the right side of L2, there was a hard feeling, but imaging was also confirmed and filling was continued as is.Cement leakage was confirmed when the device was removed. Therefore, the right L2 screw was replaced with a standard MAS.After removal, it was confirmed that the cement had not reached the hole at the tip of the screw and that almost all of it had leaked into the head.The device had been inserted slightly obliquely, and the confirmation button was also in a state where it could be pressed slightly.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 50912801 ↗
• InjurySep 16, 2026Break

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for spinal therapy. It was reported that the patient was treated with a Spondylodese Transforaminal Lumbar Interbody Fusion at 16.4.26 at segment L5/S1, with Voyager and Capstone Cage. The patient returned for a follow-up examination in July and reported pain; an X-ray taken at the clinic revealed that the 6.5 x 50 mm screw at S1 (left side) was broken. The screw was removed and replaced with a new one on (b)(6), 2026. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: Pain

  MAUDE report 50782904 ↗
• MalfunctionJul 30, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082279 ↗
• MalfunctionJul 13, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT UNDERWENT T12 VERTEBROPLASTY + T11¿L1 PERCUTANEOUS PEDICLE SCREW (PPS) FIXATION REVISION SURGERY FOR EXTENSION. IT WAS REPORTED THAT CURRENTLY T9-L1 WAS FIXED, BUT THE RIGHT L1 FENESTRATED SCREW BROKE BELOW THE SCREW HEAD. THE LEFT L1 FENESTRATED SCREW IS BENT. REOPERATION IS SCHEDULED FOR EXTENDING TO L2 AND L3. THE TIP OF THE SCREW IS PLANNED TO REMAIN IN PLACE. ADDITIONAL SCREWS WERE PLACED AT L2 AND L3, AND FIXATION WAS COMPLETED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT REOPERATION WAS PERFORMED FOR THE ADJACENT SEGMENT DISORDER. SCREWS WERE ADDED AT TH9 AND TH10, AND FIXATION WAS EXTENDED. AFTER THAT, SCREW FRACTURE AND BENDING OCCURRED. THE ADJACENT SEGMENT DISORDER OCCURRED AT VOYAGER IMPLANT AND NO IMPLANT MALFUNCTION WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN TO REMOVE THE IMPLANT. IT IS UNKNOWN FOR THE CAUSE OF ADJACENT SEGMENT DISEASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25793358 ↗
• MalfunctionJun 16, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION PROCEDURE AT L1¿L3. THE PROCEDURE WAS PERFORMED AS A REVISION SURGERY FOLLOWING A PRIOR BKP AT L2 FOR OSTEOPOROTIC COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, A GAP BETWEEN THE LOCKING OUTER SLEEVE AND THE TAB EXTENDER CAP WAS NOTICED. THE PHYSICIAN WAS CONSULTED AND INDICATED THAT IT SHOULD BE FINE AS THE BUTTON COULD NOT BE PRESSED. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED UNDER IMAGING. THE SCREW WAS REMOVED AND INSERTED AGAIN TO ADDRESS THE ISSUE. PRIOR REVISION SURGERY WAS PERFORMED FOR INSTABILITY OF THE ADJACENT VERTEBRAL BODIES, DESCRIBED AS ADJACENT SEGMENT DISEASE, AND NOT DUE TO A CEMENT PRODUCT ISSUE. IT WAS ALSO CONFIRMED THAT NO ISSUE WAS IDENTIFIED WITH THE CEMENT ITSELF AND THAT THE REPORTED CEMENT LEAKAGE DURING THE CURRENT PROCEDURE WAS ATTRIBUTED TO THE FENESTRATED SCREW ISSUE, SPECIFICALLY THE GAP BETWEEN THE LOCKING OUTER SLEEVE AND TAB EXTENDER CAP. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation

  MAUDE report 25516228 ↗
• InjuryJun 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION SPINAL THERAPY FOR L1 BURST FRACTURE. IT WAS REPORTED THAT AFTER FIXATION FROM T11/12 TO L2/3, THE L2/3 SCREW BACKED OUT SO THE L2/3 SCREW WAS REPLACED, AND ADDITIONAL SCREWS WERE INSERTED AT T10 AND L4 FOR REFIXATION. ACCORDING TO THE OPINION OF THE SURGEON, THE PATIENT¿S BONE DENSITY WAS BELOW 50. THE PHYSICIAN COMMENTED THAT THE INITIAL SURGICAL PLANNING WAS INSUFFICIENT. BECAUSE THE BONE WAS FRAGILE, IT WAS CONSIDERED UNAVOIDABLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE INITIAL SURGERY WAS PERCUTANEOUS PEDICLE SCREW: T11/12¿L2/3: L1 BURST FRACTURE VERTEBROPLASTY WAS PERFORMED. FOUR SCREWS AT L2/3 HAD BACKED OUT AND THE FOUR SCREWS WERE UPSIZED AND THE HA STICKS WERE REPLACED. FIXATION WAS EXTENDED TO T10¿L4, RESULTING IN A 3¿3 FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481456 ↗
• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3 & L5 PERCUTANEOUS PEDICLE SCREWS SPINAL THERAPY FOR 1A1B FUSION AND L4 VERTEBRAL BODY REPLACEMENT FOR L4 RUPTURED FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS INJECTED INTO THE FM OF L5, BUT IT LEAKED FROM THE SCREW HEAD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS ARE RELATED TO THE CEMENT LEAK FROM THE SCREW HEAD. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RECEIVED OTHER PRODUCTS EXTENDERS WERE IN AN ASSEMBLED STATE, AND NO DAMAGE WAS OBSERVED ON ITS EXTERIOR. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED NEAR THE CEMENT DELIVERY GUIDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445841 ↗
• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3. L5 PERCUTANEOUS PEDICLE SCREWS SPINAL THERAPY FOR 1A1B FUSION AND L4 VERTEBRAL BODY REPLACEMENT FOR L4 RUPTURED FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS INJECTED INTO THE FM OF L5, BUT IT LEAKED FROM THE SCREW HEAD. THEREWERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS ARE RELATED TO THE CEMENT LEAK FROM THE SCREW HEAD. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RECEIVED OTHER PRODUCTS EXTENDERS WERE IN AN ASSEMBLED STATE, AND NO DAMAGE WAS OBSERVED ON ITS EXTERIOR. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED NEAR THE CEMENT DELIVERY GUIDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445663 ↗
• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BALLOON KYPH OPLASTY (BKP) FOR SECONDARY FRACTURE (COMPRESSION FRACTURE). IT WAS REPORTED THAT DURING THE INJECTION OF 0.8CC OF FNS CEMENT INTO THE RIGHT SIDE OF L2, EXTRA VERTEBRAL LEAKAGE WAS IDENTIFIED THROUGH INTRAOPERATIVE FLUOROSCOPY. POSTOPERATIVE CT IMAGING REVEALED THAT THE CEMENT HAD REACHED THE INFERIOR VENA CAVA. IT HAS BEEN CONFIRMED THAT THE PATIENT IS ASYMPTOMATIC AT THIS TIME; HOWEVER, AFTER CONSULTING WITH THE CARDIOLOGY DEPARTMENT, ANTICOAGULANT THERAPY WILL BE INITIATED TO PREVENT PULMONARY EMBOLISM. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MALFUNCTION IS REPORTED WITH UNKNOWN VOYAGER IMPLANT. IT WAS ADDED TO THIS EVENT FOR A VERTEBRAL FRACTURE POST INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CEMENT LEAKED FROM THE VOYAGER FENESTRATED SCREW. THERE WERE NO MALFUNCTIONS WITH FNS TIPS AND BONE FILLER DEVICES. THEY WERE USED ALONG WITH FENESTRATED SCREW. THERE ARE NO DEFECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445333 ↗
• InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY FOR ADULT SPINAL DEFORMITY AND TH10-S2 LEVEL IMPLANT WAS PERFORMED. IT WAS REPORTED THAT THE SCREW LOOSENED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS PARTIAL REMOVAL WAS PERFORMED ON THE LEFT SIDE, TH10.11, L1.2 ADDITIONAL INFORMATION WAS RECEIVED ALL THE SCREWS WERE REMOVED FROM THE LEFT SIDE AND NO ADDITIONAL SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901731 ↗
• InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY FOR ADULT SPINAL DEFORMITY AND TH10-S2 LEVEL IMPLANT WAS PERFORMED. IT WAS REPORTED THAT THE SCREW LOOSENED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS PARTIAL REMOVAL WAS PERFORMED ON THE LEFT SIDE, TH10.11, L1.2 ADDITIONAL INFORMATION WAS RECEIVED ALL THE SCREWS WERE REMOVED FROM THE LEFT SIDE AND NO ADDITIONAL SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901714 ↗
• InjuryJan 27, 2026Leak/Splash; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT L5-S1 USING FOUR VOYAGER FNS SCREWS AUGMENTED WITH BONE CEMENT AND AN INTERBODY CAGE, INTRAOPERATIVE ASSESSMENT AND IMMEDIATE POSTOPERATIVE X-RAYS CONFIRMED SATISFACTORY PLACEMENT AND CONSTRUCT STABILITY. DURING A ROUTINE FOLLOW-UP APPOINTMENT, A SUBSEQUENT X-RAY REVEALED LOOSENING AND BACKING OUT OF A SET SCREW. REVISION SURGERY WAS PERFORMED, DURING WHICH REMOVAL OF THE EXISTING INSTRUMENTATION REVEALED BONE CEMENT LEAKAGE UNDERNEATH THE TULIP HEAD OF THE AFFECTED SCREW. THE FUSION CONSTRUCT WAS EXTENDED FROM L4 TO S1, AND NEW INSTRUMENTATION INCLUDING A BALLAST SCREW WAS PLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRIMARY REPORTED EVENT INVOLVED THE LOOSENING AND BACKING OUT OF ONE (1) SPECIFIC SCREW, WHICH WAS DIRECTLY ASSOCIATED WITH THE OBSERVED CEMENT LEAKAGE UNDER ITS TULIP HEAD. UPON VISUAL INSPECTION DURI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186513 ↗
• InjuryJan 27, 2026Leak/Splash; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT L5-S1 USING FOUR VOYAGER FNS SCREWS AUGMENTED WITH BONE CEMENT AND AN INTERBODY CAGE, INTRAOPERATIVE ASSESSMENT AND IMMEDIATE POSTOPERATIVE X-RAYS CONFIRMED SATISFACTORY PLACEMENT AND CONSTRUCT STABILITY. DURING A ROUTINE FOLLOW-UP APPOINTMENT, A SUBSEQUENT X-RAY REVEALED LOOSENING AND BACKING OUT OF A SET SCREW. REVISION SURGERY WAS PERFORMED, DURING WHICH REMOVAL OF THE EXISTING INSTRUMENTATION REVEALED BONE CEMENT LEAKAGE UNDERNEATH THE TULIP HEAD OF THE AFFECTED SCREW. THE FUSION CONSTRUCT WAS EXTENDED FROM L4 TO S1, AND NEW INSTRUMENTATION INCLUDING A BALLAST SCREW WAS PLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRIMARY REPORTED EVENT INVOLVED THE LOOSENING AND BACKING OUT OF ONE (1) SPECIFIC SCREW, WHICH WAS DIRECTLY ASSOCIATED WITH THE OBSERVED CEMENT LEAKAGE UNDER ITS TULIP HEAD. UPON VISUAL INSPECTION DURI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186511 ↗
• MalfunctionJan 5, 2026Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR VERTE BRAL FUSION AT 9TH THORACIC VERTEBRA - PELVIS (LEFT S1). PRE OP DIAGNOSIS WAS PSEUDARTHROSIS FOLLOWING FOURTH LUMBAR VERTEBRA COMPRESSION FRACTURE, FIFTH LUMBAR VERTEBRA AND SIXTH LUMBAR VERTEBRA COMPRESSION FRACTURES. IT WAS REPORTED THAT DURING SCREW INSERTION, CEMENT INJECTION PROCEDURE WAS PERFORMED USING THIS PRODUCT ON THE LEFT S1. CEMENT WAS INJECTED INTO THE VERTEBRAL BODY WITHOUT ISSUE UP TO APPROXIMATELY 1.6 CC, BUT WHEN INJECTING THE FINAL 0.2 CC, A SHADOW WAS OBSERVED AROUND THE SCREW HEAD ON THE X-RAY IMAGE, AND DIRECT VISUALIZATION CONFIRMED A SMALL AMOUNT OF CEMENT LEAKAGE. THE LEAKED CEMENT WAS REMOVED AS MUCH AS POSSIBLE, AND THIS DID NOT INTERFERE WITH THE SUBSEQUENT PROCEDURE. IT WAS CONSIDERED THAT THE ISSUE IS NOT DUE TO A DEFECT IN THE CEMENT ITSELF. IT WAS UNABLE TO BE DETERMINED WHETHER LEAKAGE WAS DUE TO BACKFLOW WITHIN THE SCREW OR LEAKAGE FROM THE TIP. 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 23959874 ↗
• MalfunctionJan 5, 2026Malposition of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT WHEN 0.8CC OF CEMENT WAS INJECTED FROM ONE SIDE INTO T10, IT WAS NOTICED THAT THE CEMENT HAD LEAKED, SO A CT SCAN WAS PERFORMED IMMEDIATELY. THE CEMENT APPEARED TO HAVE SPREAD HORIZONTALLY ACROSS THE ANTERIOR SURFACE OF THE VERTEBRAL BODY, POSSIBLY SEGMENTALLY. IT DID NOT REACH ANY MAJOR BLOOD VESSELS.NO ADDITIONAL CEMENT WAS INJECTED; THE WOUND WAS CLOSED AFTER ROD IMPLANTATION. THERE WAS NO ISSUE WITH THE SCREW ITSELF; IT WAS SUSPECTED THAT THERE ISAN ISSUE WITH SCREW PLACEMENT POSITION. 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 23959075 ↗

Other Medtronic Sofamor Danek, Inc. products

• CD HORIZON Spinal System342 models · 2,323 reports
• GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
• METRx System5 models · 672 reports
• INFUSE Bone Graft6 models · 576 reports · 1 recall
• CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
• POWEREASE Instruments8 models · 331 reports · 1 recall
• Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
• INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls