ReLine 10000425Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887517511225), received between Aug 27, 2020 and May 8, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Fracture; Fracture

  THREADED PART OF THE 4.5MM TAP BROKE OFF AND WAS LEFT IN THE PATIENT¿S RIGHT L2 VERTEBRAL BODY/PEDICLE AFTER UNSUCCESSFULLY RETRIEVING. BREAKAGE OCCURRED WHEN ATTEMPTING TO REMOVE THE TAP FROM THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21989619 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EXTREME LATERAL INTERBODY FUSION WITH POSTERIOR FIXATION, WHEN TAPPING THE PATIENT'S RIGHT L2 VERTEBRA, THE THREADED PART OF THE TAP BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21548464 ↗
• MalfunctionMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE THE SURGEON WAS TAPPING, THE DISTAL TIP OF THE TAP FRACTURED. THE FRACTURED PORTION WAS UNABLE TO BE RETRIEVED AND WAS LEFT IN-SITU. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19244070 ↗
• MalfunctionApr 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIX (6) LEVEL POSTERIOR FIXATION PROCEDURE FROM T12 TO S1. DURING THE PROCEDURE THE TIP OF THE CANNULATED TAP FRACTURED AT THE LEFT L2 PEDICLE. THE FRACTURED PORTION WAS UNABLE TO BE RETRIEVED AND WAS LEFT IN-SITU. THE PATIENT'S BONE QUALITY WAS NOTED TO BE VERY HARD. AS A RESULT, THE SURGEON DECIDED TO SKIP FIXATION OF THE LEFT L2 PEDICLE AS A SCREW WAS UNABLE TO BE IMPLANTED INTO THE SITE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16792237 ↗
• InjuryOct 14, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE FROM T9 TO L3. DURING THE PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTIES WITH TAPPING THE PILOT HOLE AT THE L1 PEDICLE. MULTIPLE ATTEMPTS WERE MADE, BUT WERE UNSUCCESSFUL IN CREATING THE PILOT HOLE. THE SURGEON OPTED TO SKIP THE L1 LEVEL AND CONTINUE THE PROCEDURE AT THE REMAINING LEVELS. THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. SUBSEQUENTLY, THE PATIENT EXPERIENCED PARALYSIS OF THE LEFT LEG POSTOPERATIVELY. CT AND MRI IMAGING WAS OBTAINED TO IDENTIFY THE CAUSE OF THE PARALYSIS, BUT NO FINDINGS WERE IDENTIFIED. THE SURGEON IS CONTINUING TO FOLLOW-UP WITH THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 15611474 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EIGHT (8) LEVEL POSTERIOR FIXATION PROCEDURE FROM T10 TO S1. DURING THE PROCEDURE, AS THE SURGEON ATTEMPTED TO TAP THE LEFT L4 PEDICLE, THE TIP OF THE CANNULATED TAP FRACTURED. THE FRACTURED PORTION WAS UNABLE TO BE RETRIEVED. NO FURTHER PATIENT IMPACT WAS REPORTED. THE PATIENT'S BONE QUALITY WAS NOTED TO BE VERY HARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 14983055 ↗
• MalfunctionAug 27, 2020Fracture; Fracture

  ON (B)(6) 2020, PATIENT UNDERWENT A TWO PART PROCEDURE. FIRST AN EXTREME LATERAL INTERBODY FUSION AT L2/3 LEVELS AND SECOND, SAME DAY A PERCUTANEOUS POSTERIOR FIXATION. IT WAS REPORTED THAT A TAP DRIVER FRACTURED WHEN A PHYSICIAN WAS INSERTING IT AT THE L4 LEVEL. THE PHYSICIAN TRIED TO REMOVE THE PIECE, HOWEVER HE COULD NOT RETRIEVE IT. THE PHYSICIAN CHANGED THE PROCEDURE FROM THE PERCUTANEOUS PEDICLE SCREW TO AN OPEN PROCEDURE WHERE THE PIECE WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462657 ↗