VERTEX® Reconstruction System 7753500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994448743), received between Mar 21, 2017 and Feb 22, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C2-T2 POSTERIOR CERVICAL FUSION DUE TO CERVICAL STENOSIS. IT WAS REPORTED THAT TOP PORTION OF SET CAP SHEARED OFF AND IT WAS EXPLANTED PARTIALLY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575616 ↗
• MalfunctionJan 19, 2022Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- MYELOPATHY INVOLVED IN THE POSTERIOR CERVICAL FUSION PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE, WHILE TORQUING THE MAS LOCKING SCREW, IT BREAKS THE BOTTOM MAS CONNECTOR. THEY COULD NOT REMOVE THIS BROKEN SETSCREW ONCE IT¿S BROKEN. THE BOTTOM OF THE MAS CONNECTORS X4 ARE STILL IN THE PATIENT BODY AS THEY HAVE BEEN STRIPPED DURING INSERTION OF CROSSLINKS X2. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON 2022-JAN-18, RECEIVED ADDITIONAL INFORMATION THAT LOT NUMBERS FOR THE REPORTED PRODUCTS ARE NOT AVAILABLE. THERE WAS A DELAY IN SURGERY, IT WOULD HAVE BEEN ABOUT 15 MINUTES. NONE OF THE ACTUAL CROSSLINKS BROKE, IT WAS THE SETSCREW THAT BREAKS WHEN IT IS FINAL TORQUED. NO REVISION SURGERY SCHEDULED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13288029 ↗
• MalfunctionDec 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR SPINAL STENOSIS, PREVIOUS LOOSENING HARDWARE. PROCEDURE OR THERAPY PERFORMED WAS POSTERIOR CERVICAL REVISION. LEVELS IMPLANTED C2-T1. IT WAS REPORTED THAT THE SET SCREW BROKE WHILE ATTEMPTING TO FINAL TIGHTEN. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. NO ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023571 ↗
• MalfunctionJun 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH T2 SPINAL ADENOMA TUMOR; AND UNDERWENT POSTERIOR CERVICO-THORACIC FUSION. INTRA-OP, THE BOTTOM CONNECTOR SET SCREW BROKE AND STRIPPED WHEN THE SURGEON WAS TORQUING OFF (TIGHTENING) THE TOP CONNECTOR LOCKING SCREW. THE BROKEN FRAGMENTS OF THE BOTTOM SET SCREW GOT STUCK IN THE TOP LOCKING SCREW. THE LOCKING SCREW WAS EXPLANTED COMPLETELY ALONG WITH THE CROSSLINK. AS THE BOTTOM SET SCREW HAD BEEN TORQUED OFF (TIGHTENED) IN THE PATIENT, THE SURGEON DID NOT REMOVE IT. NO BROKEN FRAGMENTS OF THE SET SCREW REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125561 ↗
• MalfunctionJul 19, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CERVICAL SPINE INSTABILITY TYPE OF PROCEDURE OR TECHNIQUE USED: POSTERIOR CERVICAL LATERAL MASS FUSION FROM C4-C7 LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT INTRA-OP, THE MAS CROSSLINK CONNECTOR WAS SUCCESSFULLY SECURED ONTO BOTH MAS'S AND THE CENTRE NUT WAS TIGHTENED. THE SURGEON USED THE COUNTER TORQUE AND TORQUE SET SCREW DRIVER TO "TORQUE OFF" THE LOCKING SET SCREWS BUT WHEN THIS WAS DONE IT BROKE OFF THE TOP PART OF THE MAS CONNECTOR SET SCREW WHICH REMAINS CONNECTED TO THE LOCKING SET SCREW. THERE WAS NO WAY TO RE-ATTACH THE CROSSLINK AS THE CONNECTOR SET SCREW WAS BROKEN OFF AND THERE WAS NO ATTACHMENT POINT TO GRIP ONTO. THE BOTTOM PART OF THE CONNECTOR SET SCREW WAS LEFT INSIDE THE PATIENT. NO ADDITIONAL TREATMENT OR SURGERY WERE DONE AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8806213 ↗
• MalfunctionMar 26, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: RADICULOPATHY PROCEDURE: POSTERIOR CERVICAL LEVEL IMPLANTED: C3-C7 IT WAS REPORTED THAT INTRA-OP, THE CROWN OF THE MAS CONNECTOR SET SCREW SHEARED OFF DURING THE FINAL BREAK-OFF OF THE MAS LOCKING SET SCREW. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454446 ↗
• MalfunctionMar 26, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: RADICULOPATHY PROCEDURE: POSTERIOR CERVICAL LEVEL IMPLANTED: C3-C7 IT WAS REPORTED THAT INTRA-OP, THE CROWN OF THE MAS CONNECTOR SET SCREW SHEARED OFF DURING THE FINAL BREAK-OFF OF THE MAS LOCKING SET SCREW. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454444 ↗
• MalfunctionMay 30, 2018Break; Break

  TYPE OF PROCEDURE: MAXIMUM ACCESS SURGERY (MAS) IT WAS REPORTED THAT INTRA-OP, SET SCREW HAD BEEN BROKEN DURING INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE IMPLANT REMAIN IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553759 ↗
• MalfunctionMay 3, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) AT C4/6 AND UNDERWENT POSTERIOR CERVICAL FUSION. DURING SURGERY, THE PRODUCT BROKE. THE TOP OF THE SET SCREW SHEARED OFF DURING FINAL TIGHTENING AND UNABLE TO REMOVE THE BOTTOM PORTION OF THE IMPLANT. THE SET SCREW WAS REPLACED AND UNABLE TO PLACE CROSSLINK WAS PERFORMED AS THE RESULT OF THE EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7482837 ↗
• MalfunctionMar 14, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: C4-C5 DISLOCATION TYPE OF PROCEDURE: POSTERIOR CERVICAL FIXATION USING VERTE LEVELS IMPLANTED: C2-T2 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHILE FINAL TIGHTENING OF LOCKING SCREW USING THE STRAIGHT HEX TORQUE DRIVER WITH T-HANDLE THE SET SCREW BROKEN INTO TWO PIECES. THE BROKEN SET SCREW WAS REMOVED AND EXCHANGED WITH THE NEW ONE, IT ADDED 5 MINUTES EXTRA TIME TO THE PROCEDURE. NO PATIENT COMPLICATIONS WERE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337841 ↗
• MalfunctionSep 8, 2017Break; Break

  PRE-OP DIAGNOSIS: CANAL STENOSIS LEVELS IMPLANTED: C3-T1 IT WAS REPORTED THAT INTRA-OP, THE SET SCREW BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850972 ↗
• MalfunctionMar 21, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS CERVICAL MYELOPATHY. FOR WHICH, PATIENT UNDERWENT POSTERIOR CERVICAL LATERAL MASS FUSION PROCEDURE AT LEVELS C3-C6. INTRA-OP, THE MAS EXTENSION CONNECTOR LOCKING SCREW BROKE OFF INSIDE THE MAS CROSSLINK WHEN FINAL TIGHTENING WITH THE MAS CONNECTOR SET SCREW AND STRAIGHT HEX TORQUE SHAFT AND TORQUE MINTING STRAIGHT HANDLE WAS DONE. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419824 ↗