N/A 6640004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169492509), received between Nov 6, 2020 and Feb 11, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF OF L3/4 WAS ADDED FOR THE CASE WITH FIXATED L4/5 FOR ADJACENT INTERVERTEBRAL DISORDER. IT WAS REPORTED THAT WHEN THE DRIVER WAS USED TO INSERT THE RIGHT L4 SCREW DEEPLY, THE BONE WAS HARD AND THE RESISTANCE WAS STRONG. THE SCREWDRIVER TIP BROKE AND THE SCREWDRIVER TIP REMAINED IN THE SCREW HEAD. REMOVAL WAS ATTEMPTED BUT COULD NOT BE REMOVED. THE ROD WAS SECURED AT THE PHYSICIAN'S DISCRETION WHILE LEAVING IT AS IS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MALFUNCTION IN THE INITIAL SURGERY. THE REVISION SURGERY WAS FOR ADJACENT DISC DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311197 ↗
• MalfunctionMar 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS SPONDYLOLISTHESIS, LUMBAR REGION- LUMBAR STENOSIS, LUMBAR RADICULOPATHY. IT WAS REPORTED THAT, THE BALL TIP OF A BALL-ENDED DRIVER SNAPPED OFF WHILE THE SURGEON WAS ATTEMPTING TO TIGHTEN A SET SCREW. THERE WAS UNCERTAINTY WHETHER THE BALL TIP REMAINED ENCAPSULATED IN THE SET SCREW WITHIN THE PATIENT OR IF IT WAS REMOVED BY SUCTION. PROCEDURE/TECHNIQUE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536214 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A REVISION SURG ERY FOR LUMBAR VERTEBRAL RUPTURE, FRACTURE, POST-POST-POSTERIOR FIXATION NAIL REMOVAL. DATE OF INITIAL SURGERY: (B)(6) 2019, LEVELS: L3/4/5 WITH S4 IT WAS REPORTED THAT WHEN REMOVING THE S4 SCREW WITH A BALL-END SCREWDRIVER, THE ADHESION BETWEEN THE SCREW AND BONE WAS SO STRONG THAT THE TORX NECK OF THE SCREWDRIVER BROKE OFF. THERE WERE A TOTAL OF 6 SCREWS IN L3/4/5, AND THE DRIVER BREAKAGE OCCURRED DURING THE REMOVAL OF THE LAST 6TH L5 SCREW IN THE LEFT. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE L4 RUPTURE FRACTURE WAS THE PATIENT'S SYMPTOM DURING THE PRIMARY OPERATION; IN THE CURRENT OPERATION, S4 SCREW WAS REMOVED, SO IT WAS NOT DIRECTLY RELATED TO THE MALFUNCTION. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. 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 21353604 ↗
• MalfunctionSep 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR NAIL REMOVAL. IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE THE SCREW, THE SCREWDRIVER TIP WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS  REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THE PROCEDURE OR TECHNIQUE PERFORMED WAS NAIL REMOVAL. THE PATIENT COMPLAINED ABOUT PAIN AND IT IS UNKNOWN WHETHER THE SCREW WAS THE CAUSE, BUT BECAUSE THE BONE HAD BEEN FUSED, A SCREW REMOVAL WAS PERFORMED. THE CAUSE OF THE PAIN WAS UNKNOWN. THERE WERE NO FRAGMENTS OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. NO DELAY IN OVER ALL PROCEDURE TIME REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507571 ↗
• MalfunctionJun 28, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF STENOSIS INVOLVED IN T10-PELVIS POSTERIOR FUSION PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE, THE SOLERA ROCKER ROD REDUCER BROKE WHEN THEY TRIED TO GET IT ATTACHED TO A VERY LATERAL SCREW HEAD. ONE OF THE TIPS BROKE STRAIGHT OFF INTO ONE LONG PIECE. THE BROKEN PIECE AND THE REST OF THE INSTRUMENT WERE RETRIEVED FROM THE PATIENT SUCCESSFULLY WITHOUT PATIENT HARM. THE T25 VOYAGER BALL ENDED DRIVER WAS BROKEN WHEN THEY TRIED TO ADVANCE THE LEFT L5 SCREW. THE TIP BROKE OFF INTO THE SCREW HEAD, THEY WERE ABLE TO RETRIEVE THE SCREWDRIVER TIP FROM THE PATIENT. NO PART OF THE INSTRUMENT REMAINED IN THE PATIENT. THE PATIENT HAD SCLEROTIC BONE AT THIS LEVEL AS NOTICED BY THE SURGEON. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 90 SECONDS. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075608 ↗
• InjuryNov 6, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH IMPLANT PRODUCT WHICH WAS FASTENED TO T3-ILIAC WAS REMOVED. ILIAC PART WAS THE PRIMARY REASON FOR BUTTOCK PAIN, SO ALL WAS REMOVED. PROCEDURE USED S5 WAS INSERTED INTO ILIAC SCREW WAS ATTEMPTED FOR REMOVAL. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THE TIP OF THE REPORTED DRIVER WAS BROKEN. THERE WAS OSTEOSCLEROSIS AROUND THE SCREW PLACEMENT. THOUGH THE REPORTED SCREW DRIVER TIP WAS BROKEN THE ILIAC SKIN WAS SHAVED AND THE SCREW WAS REMOVED SOMEHOW, THE ORIGINAL PURPOSE WAS ACHIEVED. NO DEVICE FRAGMENTS LEFT IN PATIENT. ADDITIONALLY REGARDING THE DRIVER BREAKAGE, OSTEOSCLEROSIS AROUND ILIAC SCREW WAS CONSIDERED TO BE THE REASON, SO THE TIP OF SCREW DRIVER WAS BROKEN. THE SURGEON ALSO CONSENTED TO THE OCCURRENCE OF THE EVENT. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. NO HEALTH DAMAGE TO PATIENT. DEVICES WILL BE RETURNED. THE PE HAS BEEN REPORTED TO HAVE TWO DRIVERS DAMAGED DURING REOPERATION. HOWEVER, THIS CASE HAS BEEN RE-OPERATED, AND THE F4.75 ROD WAS BROKEN AND THE F5.5 ROD WAS BROKEN IN THIS REOPERATION. IT WAS REPORTED THAT ONE OF THE SET SCREWS OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10799315 ↗