VersaTie 86101245Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517984296), received between Oct 14, 2022 and Dec 13, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L4 TO S2 USING ROD FIXATION AND TWO (2) SUBLAMINAR FIXATION BANDS PLACED BILATERALLY ON THE CRANIAL SIDE OF L4. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR (4) MONTHS LATER DUE TO A COMPRESSION FRACTURE AT L3, ADJACENT TO THE EXISTING FIXATION CONSTRUCT, AND KYPHOSIS. DURING THE REVISION PROCEDURE, THE BANDS WERE IDENTIFIED TO HAVE RUPTURED ON BOTH SIDES. THE REVISION WAS COMPLETED USING ROD-TO-ROD CONNECTORS AND EXTENSION OF THE FIXATION CONSTRUCT TO L3/L4 AND L2/L3. IT WAS NOTED THE PATIENT HAD WEAK BONE QUALITY, HOWEVER THERE WERE NO REPORTS OF FALLS OR OTHER TRAUMA. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965882 ↗
• InjuryDec 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L4 TO S2 USING ROD FIXATION AND TWO (2) SUBLAMINAR FIXATION BANDS PLACED BILATERALLY ON THE CRANIAL SIDE OF L4. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR (4) MONTHS LATER DUE TO A COMPRESSION FRACTURE AT L3, ADJACENT TO THE EXISTING FIXATION CONSTRUCT, AND KYPHOSIS. DURING THE REVISION PROCEDURE, THE BANDS WERE IDENTIFIED TO HAVE RUPTURED ON BOTH SIDES. THE REVISION WAS COMPLETED USING ROD-TO-ROD CONNECTORS AND EXTENSION OF THE FIXATION CONSTRUCT TO L3/L4 AND L2/L3. IT WAS NOTED THE PATIENT HAD WEAK BONE QUALITY, HOWEVER THERE WERE NO REPORTS OF FALLS OR OTHER TRAUMA. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964679 ↗
• MalfunctionNov 21, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AFTER DESIRED TENSION OF THE VERSATIE BAND WAS ACHIEVED DURING THE FINAL TIGHTENING STEP OF THE PROCEDURE, THE SURGEON NOTICED THE BAND WAS PARTIALLY TORN WITHIN THE PASSAGE WINDOW OF THE CLAMP. THE SURGEON OPTED TO KEEP BAND AND CLAMP IN PLACE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840605 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6-8 MONTHS AFTER IMPLANTATION OF VERSATIE PRODUCT, THE PATIENT DEVELOPED AN INFLAMMATORY REACTION AND POSSIBLE UNKNOWN DEFICIT. A REMOVAL PROCEDURE WAS PERFORMED WHERE THE VERSATIE WAS REMOVED AND THE PATIENT CONTINUED WITH FUSION WITH POSSIBLE EXTENSION OF CONSTRUCT. DURING REMOVAL, IT WAS NOTED THAT THE INFLAMED TISSUE WAS ADJACENT TO THE VERSATIE TETHER. PER THE REPORTER, THERE WERE NO ISSUES DURING INITIAL IMPLANTATION AND SURGICAL TECHNIQUE WAS FOLLOWED.

  Patient problems: Inflammation

  MAUDE report 15611063 ↗