SynMesh 495.365Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034785332), received between Sep 12, 2018 and Sep 12, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2018Migration; Migration

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A CERVICAL CORPECTOMY. PATIENT WAS IMPLANTED WITH ONE SYNMESH CAGE, TWO END RINGS (ASSOCIATED WITH SEGMENT ARTHRODESIS), ONE VECTRA TITANIUM (2-LEVEL) PLATE, AND FOUR 4.0MM TITANIUM CERVICAL SPINE SCREWS. POST-OPERATIVE, PATIENT EXPERIENCED IMPLANT PULL OUT OF THE 18MM SCREWS. THE FAILURE OF THE FIXATION WAS DETECTED ON (B)(6) 2018. SYMPTOMS PRESENTED IN THE POSTOPERATIVE PERIOD WAS MILD DYSPHONIA. DUE TO HIGH INSTABILITY AND RISK OF SPINAL CORD INJURY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. DURING THE REVISION, SURGEON REMOVED THE VECTRA PLATE AND SCREWS, REPOSITIONED THE IMPLANTS SYNMESH AND PLACED ANOTHER NON-SYNTHES SYSTEM CONSISTING OF AN ANTERIOR PLATE AND CERVICAL SCREWS. AFTER THE PROCEDURE, IT WAS NOTED THAT THE FIXATION WAS NOT SATISFACTORY, AND THE PATIENT WAS REVISED ON (B)(6) 2018 FOR COMPLEMENTATION OF CERVICAL FIXATION POSTERIORLY. DURING THE SURGERY, LATERAL BONE SCREWS (AXON DEPUY SYSTEM) WERE PLACED ON THE VERTEBRAE C5-C6-C7 VERTEBRAE. POSTOPERATIVELY, APPROXIMATELY AROUND (B)(6) 2018 PATIENT WAS NOTED TO BE STILL DYSPHO

  Patient problems: No Code Available

  MAUDE report 7870189 ↗
• InjurySep 12, 2018Migration; Migration

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH FOUR (4) 4.0MM TITANIUM VECTRA CERVICAL SCREWS, ONE (1) TITANIUM (TI) VECTRA PLATE (1 LEVEL 16MM), AND ONE (1) SYNTHES SYNMESH CAGE ON (B)(6) 2017. ONE MONTH POSTOPERATIVELY, THERE WAS A FIXATION FAILURE; NO ADDITIONAL SYMPTOMS NOTED. IT WAS UNSPECIFIED WHICH OF THE DEVICES HAD MALFUNCTIONED. DUE TO THE PATIENT EXHIBITING NO SYMPTOMS, THE DEVICES CONTINUE TO BE IMPLANTED. CONCOMITANT DEVICES: TI VECTRA-PLATE 2 LEVEL 30MM (PART: 04.613.130, LOT: 9770147, QUANTITY: 2); 4.0MM TI CERVICAL SELF-RETAINING SCREW SELF DRILLING ANGLE 16MM (PART: 04.613.716, LOT: L175021, QUANTITY: 2); END RING 15MM DIAMETER 2.5 DEGREES TI (PART: 495.389, LOT: 9974194, QUANTITY: 1); END RING 15MM DIAMETER 2.5 DEGREES CONVEX TI (PART: 495.416, LOT: 9898108, QUANTITY: 1). THIS REPORT IS FOR A SYNMESH® 15MM DIAMETER 32MM HEIGHT (TI). THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7869467 ↗