Medtronic Reusable Instruments 3990003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169091436), received between Sep 15, 2020 and Dec 20, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Scratched Material; Scratched Material

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR KYPHOSIS. PROCEDURE OR TECHNIQUE USED WAS PLIF. LEVELS IMPLANTED L4/5. IT WAS REPORTED THAT THE SURGEON CHOOSE A CAGE OF A NO PROBLEM SIZE WITH THE TRIAL, BUT WHEN THEY INSERTED THE CAGE, THEY COULD NOT TURN THE INSERTER. ONCE THE SURGEON PULLED OUT THE INSERTER, CAGE WAS TWISTED. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE CAGE WAS TWISTED. INSERTER TIPS WAS SLIGHTLY DEFORMED. SCRATCHES WERE FOUND AT THE TIP, THREADS NEAR THE HANDLE AND BOTTOM OF THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041266 ↗
• MalfunctionOct 7, 2021Material Deformation; Material Deformation

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-S2AI-PSF, L4/5-PLIF. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, THE SHORT INSERTER WAS FOUND TO HAVE A CRACK AT THREAD AND THE OTHER INSERTER SHAFTS WERE NOT ATTACHED TO IMPLANT DUE TO THREAD DAMAGE. THE INSERTER TIP WAS DEFORMED. THE INSERTER SHAFT WAS STRIPPED AT THE TIP AND SCRATCHES AND BURRS WERE FOUND AT THREADS ON HANDLE SIDE. THE OTHER INSERTER HAD SCRATCHES AT TIP THREADS AND SCRATCHES AND STRIPPING FOUND AT THREADS. THE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. PATIENT MEDICAL HISTORY INCLUDES HT, DM, CEREBRAL INFARCTION, TWO-SIDED TKA, DVT. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12588905 ↗
• MalfunctionOct 7, 2021Crack; Crack

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-S2AI-PSF, L4/5-PLIF. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, THE SHORT INSERTER WAS FOUND TO HAVE A CRACK AT THREAD AND THE OTHER INSERTER SHAFTS WERE NOT ATTACHED TO IMPLANT DUE TO THREAD DAMAGE. THE INSERTER TIP WAS DEFORMED. THE INSERTER SHAFT WAS STRIPPED AT THE TIP AND SCRATCHES AND BURRS WERE FOUND AT THREADS ON HANDLE SIDE. THE OTHER INSERTER HAD SCRATCHES AT TIP THREADS AND SCRATCHES AND STRIPPING FOUND AT THREADS. THE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. PATIENT MEDICAL HISTORY INCLUDES HT, DM, CEREBRAL INFARCTION, TWO-SIDED TKA, DVT. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12588821 ↗
• InjurySep 15, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPINAL PRODUCTS FOR A PLIF FOR L3/4 AND L5/S. IT WAS REPORTED THAT PLIF FOR L3/4 WAS PERFORMED AND THEN PLIF FOR L5/S WAS PERFORMED. IT WAS DECIDED TO USE THE CAGE OF 13 MM AND 18 DEGREE AFTER MEASURING BY THE TRIAL. AN ATTEMPT WAS MADE TO INSERT THE IMPLANT FROM THE LEFT SIDE AND TO ROTATE IT, BUT WHEN MORE FORCE WAS APPLIED WITHOUT ROTATING, THE INSERTER SEEMED TO COME OFF IN THE IMAGE. AT THAT POINT THE INSERTER CAME OFF FROM THE CAGE. SINCE THE CAGE WAS NOT ROTATED, THE SURGEON GRIPPED AND REMOVED THE CAGE WITH A KOCHER (CAGE 1). AFTER REPLACING TO ANOTHER IMPLANT OF THE SAME SIZE AND INSERTING AND ROTATING AGAIN WITH THE DISTRACTOR ON THE RIGHT SIDE, IT WAS SUCCESSFULLY PLACED. IT WAS ABLE TO BE ROTATED, SO IT REMAINED IN THE INTERVERTEBRAL SPACE. IT WAS INSERTED INTO THE LEFT SIDE OF L5/S AND WAS ABLE TO BE ROTATED (CAGE 3). NEXT, THE CAGE OF SAME SIZE WAS INSERTED ON THE RIGHT SIDE AND WAS ROTATED, BUT IT COULD NOT BE ROTATED EITHER, AND THE INSERTER CAME OFF. THE CAGE ON THE RIGHT SIDE WAS ALSO INSUFFICIENTLY ROTATED, BUT WHEN IT WAS TOUCHED WITH A

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

  MAUDE report 10534086 ↗