NA 487.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034782942), received between Aug 28, 2018 and Mar 2, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: --IMPLANT EXPULSION THROUGH LOCKING PLATE., PATIENT HAD REVISION SURGERY ON (B)(6) 2023 THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16470554 ↗
• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: -- IMPLANT EXPULSION THROUGH LOCKING PLATE., PATIENT HAD REVISION SURGERY ON (B)(6) 2023 THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16470549 ↗
• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: --> IMPLANT EXPULSION THROUGH LOCKING PLATE., PATIENT HAD REVISION SURGERY ON (B)(6) 2023 THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4) .

  Patient problems: Unspecified Infection

  MAUDE report 16470456 ↗
• InjuryAug 29, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CORPECTOMY WITH A SYNMESH VERTEBRAL CAGE IMPLANTED AT C6 AND A CERVICAL SPINE LOCKING PLATE (CSLP) IMPLANTED AT C5-C7. THE TWO (2) C5 CSLP SCREWS BROKE BILATERALLY ON AN UNKNOWN DATE. ACCORDING TO THE SURGEON, THE SYNMESH CAGE ALSO APPEARED TO BE SLIGHTLY SUBSIDED IN BOTH ENDPLATES. REVISION SURGERY TOOK PLACE ON (B)(6) 2018, AND THE SAME SURGEON EXPLANTED THE CSLP PLATE. WHEN REMOVING THE PLATE, THE SURGEON DISCOVERED THAT ONE (1) C7 CSLP SCREW WAS BROKEN. THE SURGEON WAS UNABLE TO REMOVE ANY OF THE SCREW FRAGMENTS WHICH WERE IDENTIFIED AS ONE (1) IN C7 AND TWO (2) IN C5. THE SYNMESH CAGE WAS NOT REMOVED. THE SURGEON THEN COMPLETED THE ANTERIOR PORTION OF THE PROCEDURE BY PLACING THE SYNAPSE ROD SYSTEM HARDWARE AT C5-C7 TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: CERVICAL SPINE LOCKING PLATE (PART# 450.231, LOT# UNKNOWN, QUANTITY# 1), LOCKING SCREW (PART# 497.78, LOT# UNKNOWN, QUANTITY# 3). THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7828736 ↗
• InjuryAug 29, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CORPECTOMY WITH A SYNMESH VERTEBRAL CAGE IMPLANTED AT C6 AND A CERVICAL SPINE LOCKING PLATE (CSLP) IMPLANTED AT C5-C7. THE TWO (2) C5 CSLP SCREWS BROKE BILATERALLY ON AN UNKNOWN DATE. ACCORDING TO THE SURGEON, THE SYNMESH CAGE ALSO APPEARED TO BE SLIGHTLY SUBSIDED IN BOTH ENDPLATES. REVISION SURGERY TOOK PLACE ON (B)(6) 2018, AND THE SAME SURGEON EXPLANTED THE CSLP PLATE. WHEN REMOVING THE PLATE, THE SURGEON DISCOVERED THAT ONE (1) C7 CSLP SCREW WAS BROKEN. THE SURGEON WAS UNABLE TO REMOVE ANY OF THE SCREW FRAGMENTS WHICH WERE IDENTIFIED AS ONE (1) IN C7 AND TWO (2) IN C5. THE SYNMESH CAGE WAS NOT REMOVED. THE SURGEON THEN COMPLETED THE ANTERIOR PORTION OF THE PROCEDURE BY PLACING THE SYNAPSE ROD SYSTEM HARDWARE AT C5-C7 TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: CERVICAL SPINE LOCKING PLATE (PART# 450.231, LOT# UNKNOWN, QUANTITY# 1); LOCKING SCREW (PART# 497.78, LOT# UNKNOWN, QUANTITY# 3). THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7828690 ↗
• InjuryAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR C6 CORPECTOMY WITH SYNTHES SYNMESH CAGE AS A VERTEBRAL BODY REPLACEMENT AND C5-C7 ANTERIOR CERVICAL PLATING WITH SYNTHES CERVICAL SPINE LOCKING PLATE (CSLP) ON MARCH 2017. THE TWO (2) C5 CSLP SCREWS BILATERALLY BROKE ON AN UNKNOWN POINT IN TIME. ACCORDING TO THE SURGEON, THE SYNMESH CAGE ALSO APPEARED TO BE SLIGHTLY SUBSIDED IN BOTH ENDPLATES. ON (B)(6) 2018, THE SAME SURGEON PERFORMED THE REVISION SURGERY AND REMOVED THE CSLP PLATE. WHEN REMOVING THE PLATE, THE SURGEON DISCOVERED THAT ONE (1) OF THE C7 CSLP SCREWS WAS BROKEN ON AN UNKNOWN SIDE. THE SURGEON COULD NOT GET ANY OF THE THREE (3) BROKEN SCREW FRAGMENTS OUT, ONE (1) IN C7 AND TWO (2) IN C5. THE SYNMESH CAGE WAS NOT REMOVED. THE SURGEON THEN COMPLETED THE ANTERIOR PORTION OF THE PROCEDURE, FLIPPED THE PATIENT PRONE AND PLACED SYNAPSE ROD SYSTEM HARDWARE AT C5-C7 TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: CERVICAL SPINE LOCKING PLATE (PART: 450.231, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART: 497.78, LOT: UNKNOWN, QUANTITY: 3), END PLATE

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7824358 ↗