n/a 6550003Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169754508), received between Jul 7, 2022 and Aug 26, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (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, 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446247 ↗
• MalfunctionMay 6, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPO RTED THAT THE INSTRUMENTS WERE BROKEN AND EXPIRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104671 ↗
• MalfunctionJan 9, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS PEDICLE SCREW FIXATION/PLACEMENT SPINAL THERAPY FOR DISCITIS. IT WAS REPORTED THAT WHILE INSERTING THE SCREW TIP WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DRIVER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017344 ↗
• MalfunctionDec 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T12-L2 POSTERIOR SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE. IT WAS REPORTED THAT TIP OF THE DRIVER BROKE OFF. 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 23808691 ↗
• MalfunctionAug 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED FOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT DRIVER HEAD SNAPPED OFF. THE ROD INSERTED DOES NOT LOCK DOWN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904397 ↗
• MalfunctionAug 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT INSTRUMENTS WERE FOUND BROKEN IN A STORAGE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837098 ↗
• MalfunctionFeb 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR SPINAL FUSION (PSF) AT LEVELS L4-S1. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS POSTERIOR SPINAL FUSION (PSF). IT WAS REPORTED THAT WHILE PLACING THE VOYAGER ILIAC SCREWS, THE NAV DRIVER TIP SNAPPED OFF AND SUBSEQUENT ATTEMPTS TO ADVANCE THE SCREW WITH OTHER DRIVERS AND INSTRUMENTS ALSO RESULTED IN BREAKAGE. AND THE END OF THE HEAD TURNER DRIVER WAS MORPHED. THE SCREW WAS REMOVED AND REPLACED WITH ONE OF A SMALLER DIAMETER. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467587 ↗
• MalfunctionFeb 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF DRIVER SHEARED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429759 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A REDUCER AND DRIVER USED FOR TL IF. IT WAS REPORTED THAT THE REDUCER BROKE AND THE TIP OF DRIVER BROKE OFF WHILE ADJUSTING A SCREW. REDUCER WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353510 ↗
• MalfunctionFeb 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT DURING INVENTORY, IT WAS DISCOVERED THAT THE TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341342 ↗
• MalfunctionFeb 4, 2025Break; Break

  THE TYPE OF PROCEDURE INVOLVED IN THIS EVENT WAS REVISION TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). AND THE ALLEGATION WAS NOTICED WHEN THE SCRUB TECH WAS SETTING UP TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304294 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THE DRIVERS WERE BROKEN WHILE RESETTING THE TRAYS. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237024 ↗
• MalfunctionJan 8, 2025Degraded; Degraded

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR PSF. IT WAS REPORTED THAT THE DEVICES HAVE NORMAL WEAR <(>&<)> TEAR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099555 ↗
• MalfunctionJan 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING PERCUTANEOUS PSF L4-S1. IT WAS REPORTED THAT DURING AN INSTRUMENT INSPECTION PRIOR TO THE PATIENT BEING IN THE ROOM, THE TIP OF THE VOYAGER T25 NON-RETAINING DRIVER WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077728 ↗
• MalfunctionAug 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS USING THE DRIVER TO ADJUST A PEDICLE SCREW AND THEN THE TIP BROKE OFF. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

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

  MAUDE report 20023313 ↗
• MalfunctionAug 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-S1 ORTHODONTIC FIXATION FOR L4 RUPTURE FRACTURE. IT WAS REPORTED THAT THE SCREW OF L5 WAS INSERTED FROM THE OUTSIDE WHEN V5 WAS USED, SO IT COULD NOT BE CONNECTED TO THE S1 SCREW. THE CONNECTION WAS MADE USING A LATERAL CONNECTOR, BUT SINCE THE VOYAGER DID NOT HAVE THE EQUIPMENT TO CUT THE SCREW, THE PHYSICIAN DECIDED NOT TO CUT THE SCREW, BUT TO CRIMP IT TIGHTLY WITH A T25. AT THAT TIME, THE SCREWDRIVER WAS DAMAGED (THE SCREWDRIVER TIP WAS NOT SCREWED), SO IT WAS BURIED IN THE SCREW HOLE OF THE LATERAL CONNECTOR. THERE WAS NO PATIENT SYMPTOM REPORTED. NO ADDITIONAL SURGERY WAS PERFORMED OR PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19904365 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING NORMAL INSTRUMENT SERVICING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399485 ↗
• MalfunctionMar 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. PRE-OP DIAGNOSIS: FLATBACK SYNDROME OF LUMBAR SPINE PROCEDURE INVOLVED: L2-3 LATERAL LUMBAR INTERBODY FUSION, L3-4 REMOVAL OF HARDWARE, L2-S1 (POSSIBLY PELVIS) POSTEROLATERAL FUSION WITH PEDICLE SCREW INSTRUMENTATION, AND POSSIBLE MULTILEVEL POSTERIOR COLUMN OSTEOTOMY. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER SHEARED OFF WHILE BACKING OUT A SCREW. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. 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 16493302 ↗
• MalfunctionOct 21, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER TIPS SHEERED DURING TIGHTENING OF THE SET SCREWS. THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

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

  MAUDE report 15648534 ↗
• MalfunctionJul 7, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED IN SPINAL FUSION THERAPY FOR REMOVAL OF FOREIGN OBJECT. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO REMOVE THE LEFT IL SCREW WITH NON-STERILE PRODUCT, THE TIP OF THE DRIVER WAS COMPLETELY BROKEN AND LOST INSIDE THE SCREW SHAFT. AFTERWARD, THE SCREW COULD BE REMOVED, BUT THE BROKEN PART OF THE SHAFT WAS LEFT INSIDE THE SCREW PART. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT LOT NUMBER OF THE REPORTED PRODUCT IS KH17J873. THERE IS NO MALFUNCTION ASSOCIATED WITH THE MDT PRODUCTS USED IN INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942274 ↗