NA 498.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034788883), received between Mar 10, 2017 and Oct 26, 2021 — classified as 8 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE) AND COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. LATER THE PATIENT UNDERWENT A T10/11 CORPECTOMY WITH CAGE PLACEMENT AND T8-L1 PEDICLE SCREW FIXATION ON (B)(6) 2018. THE PATIENT PRESENTED WITH PAIN AROUND (B)(6) 2021 AND SUBSEQUENT IMAGING SHOWED THE FOLLOWING HARDWARE FAILURE: FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE). COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE OF THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. ON (B)(6) 2021, THE SURGEON REVISED THE BROKEN RODS POSTERIORLY AND PLACED FOUR COCR RODS WITH PARALLEL CONNECTORS TO STABILIZE THE SPINE. THE SURGEON RESECTED SCAR TISSUE POSTERIORLY TO FREE UP THE DAMAGED CAGE AS MUCH AS POSSIBLE. AFTER THE INTRA-OPERATIVE ASSESSMENT, THE SURGEON DETERMINED IT WOULD BE BEST TO REVISE THE CAGE ANTERIORLY WITH THE HELP OF THE THORACIC AND VASCULAR SURGEONS. ON (B)(6) 2021, THE SURGEON WAS ABLE TO SAFELY EXTRACT THE BROKEN CAGE. SCAR TISSUE HAD FORMED ACROSS THE T10/11 LEVEL, ADHERING THE CAGE TO VAS

  Patient problems: Pain

  MAUDE report 12697495 ↗
• InjuryOct 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE) AND COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. LATER THE PATIENT UNDERWENT A T10/11 CORPECTOMY WITH CAGE PLACEMENT AND T8-L1 PEDICLE SCREW FIXATION ON (B)(6) 2018. THE PATIENT PRESENTED WITH PAIN AROUND (B)(6) 2021 AND SUBSEQUENT IMAGING SHOWED THE FOLLOWING HARDWARE FAILURE: FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE). COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE OF THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. ON (B)(6) 2021, THE SURGEON REVISED THE BROKEN RODS POSTERIORLY AND PLACED FOUR COCR RODS WITH PARALLEL CONNECTORS TO STABILIZE THE SPINE. THE SURGEON RESECTED SCAR TISSUE POSTERIORLY TO FREE UP THE DAMAGED CAGE AS MUCH AS POSSIBLE. AFTER THE INTRA-OPERATIVE ASSESSMENT, THE SURGEON DETERMINED IT WOULD BE BEST TO REVISE THE CAGE ANTERIORLY WITH THE HELP OF THE THORACIC AND VASCULAR SURGEONS. ON (B)(6) 2021, THE SURGEON WAS ABLE TO SAFELY EXTRACT THE BROKEN CAGE. SCAR TISSUE HAD FORMED ACROSS THE T10/11 LEVEL, ADHERING THE CAGE TO VAS

  Patient problems: Pain

  MAUDE report 12697471 ↗
• InjuryNov 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BROKEN OF THE BILATERAL RODS AT AROUND T12 LEVEL. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION USING CONSTRUCT SYNTHES UNIVERSAL SPINAL SYSTEM (USS) IN (B)(6) 2019. THERE WERE BILATERAL CRANIAL RODS WITH UNKNOWN SCREWS FROM T6-T11 THAT WERE CONNECTED WITH A PARALLEL CONNECTOR AT THE T12 LEVEL THAT WAS CONNECTED TO BILATERAL L1-ILIUM USS CONSTRUCTS. ESSENTIALLY, THE CONSTRUCT RAN FROM T6-ILIUM WITH SCREWS AT EVERY LEVEL EXCEPT T12 WHERE THE ROD TO ROD CONNECTORS WERE. HOWEVER, THE RODS WERE BROKEN JUST ABOVE THE PARALLEL CONNECTOR ON THE CRANIAL ROD CONSTRUCT. THUS, THE REVISION WAS DONE, WHEREIN THE SURGEON REMOVED THE CRANIAL RODS AND PARALLEL CONNECTORS AND PLACED WITH A NEW PARALLEL CONNECTORS AND CONTOURED NEW CRANIAL RODS. THEN, THE SURGEON CONNECTED THEM TO THE CAUDAL RODS AND CONNECTED THE RODS TO THE CRANIAL SCREWS AND TIGHTENED EVERYTHING DOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCES. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN), PARALLEL CONNECTOR (PART #: 498.160,

  Patient problems: No Code Available

  MAUDE report 9316765 ↗
• InjuryNov 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BROKEN OF THE BILATERAL RODS AT AROUND T12 LEVEL. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION USING CONSTRUCT SYNTHES UNIVERSAL SPINAL SYSTEM (USS) IN (B)(6) 2019. THERE WERE BILATERAL CRANIAL RODS WITH UNKNOWN SCREWS FROM T6-T11 THAT WERE CONNECTED WITH A PARALLEL CONNECTOR AT THE T12 LEVEL THAT WAS CONNECTED TO BILATERAL L1-ILIUM USS CONSTRUCTS. ESSENTIALLY, THE CONSTRUCT RAN FROM T6-ILIUM WITH SCREWS AT EVERY LEVEL EXCEPT T12 WHERE THE ROD TO ROD CONNECTORS WERE. HOWEVER, THE RODS WERE BROKEN JUST ABOVE THE PARALLEL CONNECTOR ON THE CRANIAL ROD CONSTRUCT. THUS, THE REVISION WAS DONE, WHEREIN THE SURGEON REMOVED THE CRANIAL RODS AND PARALLEL CONNECTORS AND PLACED WITH A NEW PARALLEL CONNECTORS AND CONTOURED NEW CRANIAL RODS. THEN, THE SURGEON CONNECTED THEM TO THE CAUDAL RODS AND CONNECTED THE RODS TO THE CRANIAL SCREWS AND TIGHTENED EVERYTHING DOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCES. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), PARALLEL CONNECTOR (PART # 498.160, LOT

  Patient problems: No Code Available

  MAUDE report 9316743 ↗
• InjuryApr 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION DUE TO BROKEN LEFT ROD. THE PATIENT PREVIOUSLY HAD A POSTERIOR SPINAL FUSION EXTENSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) IN (B)(6) 2018. THE SYNTHES SPINE USS HARDWARE EXTENDED NON-SYNTHES T10-S1 HARDWARE TO T7 USING ROD TO ROD CONNECTORS. THE SYNTHES USS SCREWS WERE PLACED IN T7-T11 AND WERE CONNECTED TO THE OLDER HARDWARE CAUDAL TO THE NEW CONSTRUCT. AT AN UNKNOWN POINT IN TIME, THE LEFT SYNTHES ROD BROKE JUST CAUDAL TO THE T11 SCREW. THE SURGEON REMOVED THE USS NUTS, COLLARS, AND TWO (2) RODS. HE THEN REPLACED BOTH OF THE RODS WITH NEW RODS OF THE SAME TYPE. HE ALSO USED THE SAME CONNECTORS AND COMPLETED THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES: USS NUTS (PART: 498.003, LOT: UNKNOWN, QUANTITY: UNKNOWN), USS COLLARS (PART: 498.010, LOT: UNKNOWN, QUANTITY: UNKNOWN), USS ROD (PART: 498.108, LOT: UNKNOWN, QUANTITY: UNKNOWN), USS SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) . THIS REPORT IS FOR A 6.0MM TITANIUM (TI) HARD ROD 200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8529262 ↗
• InjuryJan 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF THE BROKEN TITANIUM HARD ROD DUE TO NONUNION IN THE LUMBAR 2 (L2) AREA. THE PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2017 ON AN UNKNOWN DATE. THE PATIENT HAD SYNTHES USS HARDWARE FROM T10-ILIUM. THERE WERE 2 CONNECTED CONSTRUCTS CONNECTED BY THE PARALLEL CONNECTORS AT THE L2 LEVEL. THE UPPER SET OF RODS HAD USS SCREWS FROM T10-L1. THE LOWER CONSTRUCT HAD USS SCREWS FROM L3-ILIUM. THERE WERE NO SCREWS IN THE L2 LEVEL WHERE THE ROD TO ROD PARALLEL CONNECTORS WERE PLACED. THE PATIENT BROKE THE LEFT ROD JUST CRANIAL TO THE PARALLEL CONNECTOR AT L2 (CRANIAL CONSTRUCT ROD). DURING THE REVISION, THE SURGEON REMOVED THE UPPER RODS AND THE TITANIUM PARALLEL CONNECTORS. ONLY THE LEFT UPPER ROD WAS BROKEN. THE SURGEON PLACED NEW UNKNOWN SCREWS AT THORACIC 8(T8) AND THORACIC 9 (T9). THE SURGEON CONTOURED TWO (2) NEW TITANIUM HARD RODS AND PLACED NEW PARALLEL CONNECTORS ON THE EXISTING RODS THAT RUN TO THE LOWER CONSTRUCT FROM L3-ILIUM. THE SURGEON THEN REMOVED THE RODS AND CONNECTED THE UPPER RODS TO THE UNKNOWN SCREWS AND NEW TITANIUM PARALLEL CONNECTORS. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN ROD. THE PROCED

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8290427 ↗
• InjuryMar 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO A NONUNION AND TWO BROKEN 6.0 MM TITANIUM (TI) HARD RODS. PATIENT HAD A POSTERIOR L2-ILIUM SPINE FUSION PROCEDURE WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS) HARDWARE ON AN UNKNOWN DATE IN (B)(6) 2016. THE PATIENT WAS IMPLANTED WITH TWO (2) 6.0 MM TI HARD RODS, TWELVE (12) USS SCREWS OF UNKNOWN SIZES, TWELVE (12) TI NUTS, AND TWELVE (12) 6.0 MM TI COLLARS. ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THE PATIENT DID NOT HEAL AT THE L5-S1 LEVEL AND IT WAS FOUND THAT THE RODS BROKE JUST CRANIAL TO THE S1 SCREWS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN RODS. THE SURGEON REMOVED ALL SYNTHES USS HARDWARE AT L2-ILIUM. THE BROKEN RODS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE SURGEON IMPLANTED NEW SYNTHES USS HARDWARE AT L2-ILIUM. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT STATUS/OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: USS SCREWS (PARTIAL PART# 498.XXX, QTY 12). TI NUT 11 MM WIDTH ACROSS FLATS (PART# 498.003, QTY 12). 6.0 MM TI COLLAR (PART# 498.010, QTY 12). THIS RE

  Patient problems: Failure of Implant; Impaired Healing; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6395140 ↗
• InjuryMar 10, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO A NONUNION AND TWO BROKEN 6.0MM TITANIUM (TI) HARD RODS. PATIENT HAD A POSTERIOR L2-ILIUM SPINE FUSION PROCEDURE WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS) HARDWARE ON AN UNKNOWN DATE IN (B)(6) 2016. THE PATIENT WAS IMPLANTED WITH TWO (2) 6.0MM TI HARD RODS, TWELVE (12) USS SCREWS OF UNKNOWN SIZES, TWELVE (12) TI NUTS, AND TWELVE (12) 6.0MM TI COLLARS. ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THE PATIENT DID NOT HEAL AT THE L5-S1 LEVEL AND IT WAS FOUND THAT THE RODS BROKE JUST CRANIAL TO THE S1 SCREWS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN RODS. THE SURGEON REMOVED ALL SYNTHES USS HARDWARE AT L2-ILIUM. THE BROKEN RODS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE SURGEON IMPLANTED NEW SYNTHES USS HARDWARE AT L2-ILIUM. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT STATUS/OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: USS SCREWS (PARTIAL PART# 498.XXX, LOT# UNKNOWN, QTY 12). TI NUT 11MM WIDTH ACROSS FLATS (PART# 498.003, LOT# UNKNOWN, QTY 12). 6.0MM TI COLLAR (PART# 49

  Patient problems: Failure of Implant; Impaired Healing; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6395129 ↗