NA 04.641.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034749839), received between Jun 5, 2019 and Jan 10, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K142587); they may or may not involve this specific model.

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.

• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A BILATERAL REVISION OF SUPERIOR CRADLE SURGERY WITH THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR), THE HEX COUPLING NUTS OF THREE (3) SMALL TITANIUM (TI) RIB HOOK WERE STRIPPED. ORIGINALLY, THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE. THE SMALL TITANIUM RIB HOOKS WERE THE CHOICE OF IMPLANTS FOR REPLACEMENT BILATERALLY. HOWEVER, UPON FINAL TIGHTENING USING AN UNKNOWN 5NM TORQUE LIMITING HANDLE WITH AN UNKNOWN VEPTR NUT DRIVER SHAFT, THE 6MM HEX COUPLING OF THE SMALL RIB HOOKS WERE NOT ACHIEVED AND WERE BELIEVED THAT THE HEX COUPLING NUTS OF THE SMALL RIB HOOKS WERE STRIPPED. THE FINAL TIGHTENING WAS FINALLY ACHIEVED AFTER SWITCHING OUT THE THREE SMALL TITANIUM RIB HOOKS. THERE WAS A SURGICAL DELAY OF 30 MINUTES. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TORQUE LIMITING HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN VEPTR NUT DRIVER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN RIB HOOK CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN CLOSURE FOR EXTENSION BAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN EXTENSION BAR (PART# UNKNOWN, LOT# UN

  Patient problems: Not Applicable

  MAUDE report 9578813 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A BILATERAL REVISION OF SUPERIOR CRADLE SURGERY WITH THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR), THE HEX COUPLING NUTS OF THREE (3) SMALL TITANIUM (TI) RIB HOOK WERE STRIPPED. ORIGINALLY, THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE. THE SMALL TITANIUM RIB HOOKS WERE THE CHOICE OF IMPLANTS FOR REPLACEMENT BILATERALLY. HOWEVER, UPON FINAL TIGHTENING USING AN UNKNOWN 5NM TORQUE LIMITING HANDLE WITH AN UNKNOWN VEPTR NUT DRIVER SHAFT, THE 6MM HEX COUPLING OF THE SMALL RIB HOOKS WERE NOT ACHIEVED AND WERE BELIEVED THAT THE HEX COUPLING NUTS OF THE SMALL RIB HOOKS WERE STRIPPED. THE FINAL TIGHTENING WAS FINALLY ACHIEVED AFTER SWITCHING OUT THE THREE SMALL TITANIUM RIB HOOKS. THERE WAS A SURGICAL DELAY OF 30 MINUTES. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TORQUE LIMITING HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN VEPTR NUT DRIVER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN RIB HOOK CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN CLOSURE FOR EXTENSION BAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN EXTENSION BAR (PART# UNKNOWN, LOT# UN

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9578780 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A BILATERAL REVISION OF SUPERIOR CRADLE SURGERY WITH THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR), THE HEX COUPLING NUTS OF THREE (3) SMALL TITANIUM (TI) RIB HOOK WERE STRIPPED. ORIGINALLY, THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE. THE SMALL TITANIUM RIB HOOKS WERE THE CHOICE OF IMPLANTS FOR REPLACEMENT BILATERALLY. HOWEVER, UPON FINAL TIGHTENING USING AN UNKNOWN 5NM TORQUE LIMITING HANDLE WITH AN UNKNOWN VEPTR NUT DRIVER SHAFT, THE 6MM HEX COUPLING OF THE SMALL RIB HOOKS WERE NOT ACHIEVED AND WERE BELIEVED THAT THE HEX COUPLING NUTS OF THE SMALL RIB HOOKS WERE STRIPPED. THE FINAL TIGHTENING WAS FINALLY ACHIEVED AFTER SWITCHING OUT THE THREE SMALL TITANIUM RIB HOOKS. THERE WAS A SURGICAL DELAY OF 30 MINUTES. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TORQUE LIMITING HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN VEPTR NUT DRIVER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN RIB HOOK CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN CLOSURE FOR EXTENSION BAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN EXTENSION BAR (PART# UNKNOWN, LOT# UN

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9578779 ↗
• MalfunctionJun 5, 2019Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SPINE PROCEDURE. DURING THE PROCEDURE, THE NUT OF A RIB HOOK WOULD NOT LOCK WITH THE TORQUE LIMITING WRENCH AND WOULD JUST KEEP SPINNING. THE SURGEON TIGHTENED ANOTHER RIB HOOK TO VERIFY THE TORQUE LIMITING DEVICE WAS NOT THE ISSUE. THE SURGEON THEN REMOVED THE MALFUNCTIONING RIB HOOK AND REPLACED IT WITH A DIFFERENT IDENTICAL HOOK. THERE WAS A FIFTEEN (15) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TORQUE LIMITING WRENCH (PART/LOT UNKNOWN, QUANTITY 1); LOCKING CAPS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A RIB HOOK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142587. One submission often covers many models, so check the product and lot details in each record.

• Z-2488-2015 · Jul 29, 2015 · Terminated
  VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic de