NA 498.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034788869), received between Dec 12, 2017 and Jun 3, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY IN (B)(6) 2021 (UNKNOWN DAY), THE SURGEON PERFORMED AN L3-S1 POSTERIOR SPINAL FUSION ON THE PATIENT FOR A TRAUMATIC L4-L5 FRACTURE-DISLOCATION. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE BOTH RODS BETWEEN L4 AND L5. THE PATIENT ESTIMATES THE RODS BROKE AT ABOUT THE 12-WEEK POST-OP DATE. ON (B)(6) 2021, THE SURGEON PERFORMED THE REVISION TO ADDRESS THE BROKEN RODS. HE REMOVED BOTH THE RODS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 6.0MM TI HARD ROD 125MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931536 ↗
• InjuryJun 3, 2021Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY IN (B)(6) 2021 (UNKNOWN DAY), THE SURGEON PERFORMED AN L3-S1 POSTERIOR SPINAL FUSION ON THE PATIENT FOR A TRAUMATIC L4-L5 FRACTURE-DISLOCATION. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE BOTH RODS BETWEEN L4 AND L5. THE PATIENT ESTIMATES THE RODS BROKE AT ABOUT THE 12-WEEK POST-OP DATE. ON (B)(6) 2021, THE SURGEON PERFORMED THE REVISION TO ADDRESS THE BROKEN RODS. HE REMOVED BOTH THE RODS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 6.0MM TI HARD ROD 125MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931532 ↗
• MalfunctionJan 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6), 2021, THE FLEXIBLE SCREWDRIVER WAS FOUND BROKEN AT STERILE PROCESSING DEPARTMENT. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. CONCOMITANT DEVICE REPORTED: 6.0MM TI HARD ROD 125MM, LOT #2L80007, QTY # UNK. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 125MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243545 ↗
• InjuryJul 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT REMOVAL OF THE POSTERIOR UNIVERSAL SPINAL SYSTEM (USS) FOLLOWED BY AN ANTERIOR CORPECTOMY OF DUE TO A BROKEN HARD ROD. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A USS SYSTEM ON AN UNKNOWN DATE AND THERE WERE NO SCREWS IMPLANTED. AT AN UNKNOWN TIME AFTER THE INITIAL SURGERY, THE PATIENT BROKE THE RIGHT HARD ROD JUST CRANIAL TO THE RIGHT UNKNOWN SCREW. IT IS UNKNOWN HOW THE BROKEN HARD ROD WAS DISCOVERED. DURING THE REVISION, THE SURGEON PLACED A STRYKER V-LIFT EXPANDABLE CAGE. THE SURGEON THEN FLIPPED THE PATIENT TO A POSTERIOR POSITION AND REMOVED ALL THE SYNTHES USS HARDWARE AND AS VERIFIED THE RIGHT HARD ROD WAS BROKEN. THE SURGEON THEN PLACED THE NEW UNKNOWN SCREWS A. THE SURGEON ALSO USED DEPUY SYNTHES SPINE EXPEDIUM SYSTEM AND DID NOT REPLACE THE SCREWS AT AS THE SURGEON FELT THAT THE PATIENT DOESN'T NEED THEM. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN HOOKS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). UNKNOWN COLLAR (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). UNKNOWN NUTS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). UNKNOWN USS SCREWS (PART # UNKNOWN, LOT # U

  Patient problems: No Code Available

  MAUDE report 10291980 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD AN L4-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS). AT AN UNKNOWN TIME, THE PATIENT DEVELOPED BACK PAIN, AND ALSO AN ADJACENT LEVEL DISC DISEASE ABOVE THE FUSION. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2018, THEN REMOVED ALL THE NUTS, COLLARS, AND BOTH RODS. WHILE REMOVING THE RODS, THE SURGEON DISCOVERED THAT THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE LEFT S1 SCREW. THE SURGEON PLACED A NEW USS SCREWS AT L2 AND L3, AND CONTOURED NEW RODS, AND CONNECTED THEM TO THE SCREWS FROM L2-ILIUM. THE SURGEON DID NOT REPLACE ANY OF THE L4-ILIUM SCREWS FROM THE (B)(6) 2018 SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 5 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7916469 ↗
• InjurySep 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD AN L4-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS). AT AN UNKNOWN TIME, THE PATIENT DEVELOPED BACK PAIN, AND ALSO AN ADJACENT LEVEL DISC DISEASE ABOVE THE FUSION. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2018, THEN REMOVED ALL THE NUTS, COLLARS, AND BOTH RODS. WHILE REMOVING THE RODS, THE SURGEON DISCOVERED THAT THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE LEFT S1 SCREW. THE SURGEON PLACED A NEW USS SCREWS AT L2 AND L3, AND CONTOURED NEW RODS, AND CONNECTED THEM TO THE SCREWS FROM L2-ILIUM. THE SURGEON DID NOT REPLACE ANY OF THE L4-ILIUM SCREWS FROM THE (B)(6) 2018 SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7916422 ↗
• InjuryFeb 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2016 AND WAS IMPLANTED WITH SYNTHES HARDWARE. THE PATIENT HAS SYNTHES USS HARDWARE FROM T10-ILIUM. THERE ARE USS SCREWS IN EVERY LEVEL FROM T10-ILIUM EXCEPT L3. AT THE L3 LEVEL THERE ARE BILATERAL PARALLEL CONNECTORS CONNECTING 2 RODS (ROD ABOVE L3 AND SEPARATE ROD BELOW L3 - BOTH SIDES). AT AN UNKNOWN TIME, THE LOWER RODS BROKE AT THE L3-4 LEVEL BILATERALLY JUST BELOW THE PARALLEL CONNECTOR. THE PATIENT EXPERIENCES BACK PAIN. ON (B)(6) 2018 SURGEON PERFORMED THE REVISION TO ADDRESS THE BROKEN RODS. ALL FRAGMENT PIECES WERE RETRIEVED. HE REMOVED ALL THE USS NUTS AND COLLARS AND REMOVED THE RODS. HE THEN PLACED 2 NEW USS SCREWS AT THE T9 LEVEL TO EXTEND THE CONSTRUCT. HE THEN CONTOURED NEW RODS TO SPAN THE ENTIRE LENGTH OF THE CONSTRUCT FROM T9-ILIUM. HE THEN CONNECTED THE RODS AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO SURGICALL DELAY WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED FINE. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (498.003, LOT NUMBER UNKNOWN, QUANTITY 4), 6.0MM TITANIUM COLLAR (498.010, LOT NUMBER UNKNOWN, QUANTITY 4), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNO

  Patient problems: Failure of Implant; Pain

  MAUDE report 7267648 ↗
• InjuryFeb 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2016 AND WAS IMPLANTED WITH SYNTHES HARDWARE. THE PATIENT HAS SYNTHES USS HARDWARE FROM T10-ILIUM. THERE ARE USS SCREWS IN EVERY LEVEL FROM T10-ILIUM EXCEPT L3. AT THE L3 LEVEL THERE ARE BILATERAL PARALLEL CONNECTORS CONNECTING 2 RODS (ROD ABOVE L3 AND SEPARATE ROD BELOW L3 - BOTH SIDES). AT AN UNKNOWN TIME, THE LOWER RODS BROKE AT THE L3-4 LEVEL BILATERALLY JUST BELOW THE PARALLEL CONNECTOR. THE PATIENT EXPERIENCES BACK PAIN. ON (B)(6) 2018 SURGEON PERFORMED THE REVISION TO ADDRESS THE BROKEN RODS. ALL FRAGMENT PIECES WERE RETRIEVED. HE REMOVED ALL THE USS NUTS AND COLLARS AND REMOVED THE RODS. HE THEN PLACED 2 NEW USS SCREWS AT THE T9 LEVEL TO EXTEND THE CONSTRUCT. HE THEN CONTOURED NEW RODS TO SPAN THE ENTIRE LENGTH OF THE CONSTRUCT FROM T9-ILIUM. HE THEN CONNECTED THE RODS AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO SURGICALL DELAY WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED FINE. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (498.003, LOT NUMBER UNKNOWN, QUANTITY 4), 6.0MM TITANIUM COLLAR (498.010, LOT NUMBER UNKNOWN, QUANTITY 4), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNO

  Patient problems: Failure of Implant; Pain

  MAUDE report 7267635 ↗
• InjuryDec 12, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO BROKEN RODS OF POSTERIOR SYNTHES UNIVERSAL SPINE SYSTEM (USS) HARDWARE AND NON-UNION/DELAYED HEALING. THE PATIENT HAS POSTERIOR SYNTHES USS HARDWARE FROM T7-S1. THE CURRENT CONSTRUCT HAS SCREWS AT EVERY LEVEL EXCEPT T10 AND L3. THERE IS A PARALLEL (ROD TO ROD) CONNECTOR AT L3 THAT CONNECTS TWO (2) RODS ON EACH SIDE OF THE CONSTRUCT (ROD CRANIAL TO L3 AND ROD CAUDAL TO L3 BILATERALLY). THE PATIENT BROKE BOTH RODS BILATERALLY JUST CRANIAL TO THE PARALLEL CONNECTOR ON AN UNKNOWN DATE. THE SURGEON THOUGHT THAT THE LATERAL BEND OF THE ROD TO MAKE UP FOR THE OFFSET IN THE CONNECTOR MIGHT HAVE WEAKENED THE ROD AS THE BREAKAGE OF BOTH RODS IS AT THE BASE OF THAT LATERAL BEND. THE CRANIAL RODS THAT RUN FROM T7-L3 WERE PLACED ON (B)(6) 2017. THESE WERE THE RODS THAT BROKE. THE RODS EACH BROKE INTO TWO (2) PIECES WITHOUT FRAGMENTS. THE SURGEON REMOVED ALL THE NUTS, COLLARS, TWO (2) CRANIAL RODS AND EIGHT (8) SCREWS WITHOUT ISSUE. THE REST OF THE HARDWARE REMAINED INTACT. THE CRANIAL RODS THAT WERE IN THE CRANIAL SCREWS BILATERALLY WERE 6.0 MM TI HARD RODS. THE CAUDAL RODS DID NOT HAVE ANY MARKINGS ON THEM. THE S

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7110187 ↗