VERTEX® Reconstruction System 7752529Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994454041), received between Sep 1, 2017 and Dec 20, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionDec 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  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 MALFUNCTION WAS REPORTED FOR THE ALLEGED CROSSLINK LOCKING SCREW. 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 9502451 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL FIXATION SURGERY WITH OCCIPUT DUE TO SOME UNKNOWN REASONS. INTRA-OP, WHILE TIGHTENING THE SET SCREW WITH TORQUE LIMITING TOOL, THE UPPER PART OF THE SET SCREW BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8013546 ↗
• 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 PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482780 ↗
• MalfunctionApr 20, 2018Break; Break

  IT WAS REPORTED THAT POSTERIOR CERVICAL FUSION AT C4-T1 DUE TO SPINAL STENOSIS. INTRA-OP, THE IMPLANT BROKE. THE LOCK SCREW WAS FIRST TORQUED TO ROD. WHEN TIGHTENING THE SET SCREW INTO LOCK SCREW TO HOLD DOWN MAS CROSSLINK, THE IMPLANT BROKE. THE LOWER PORTION OF THE LOCK SCREW REMAINED BUT THE HOLLOW TOP PART OF THE SCREW BROKE OFF. THERE WAS NO WAY TO REMOVE THE LOCKING SCREW BECAUSE THE TOP OF THE LOCK SCREW IS NEEDED TO ACCESS THREADS OR OUTSIDE GRIP. ROD REMAINED TORQUED IN PLACE SO DOCTOR DECIDED TO LEAVE THE BROKEN LOCK SCREW IN THE PATIENT WITHOUT COMPLICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446005 ↗
• MalfunctionFeb 27, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR CERVICAL FUSION AT C3-C6 DUE TO CENTRAL CANAL STENOSIS OF CERVICAL SPINE WITH PARALYSIS. INTRA-OP, SET SCREW SHEARED. THE MAS CROSS LINK WAS PLACED OVER THE MALE HEX POST AND WHILE PLACING THE MAS CROSSLINK LOCKING SET NUT, THE MALE HEX POST SHEARED OFF. THE RESIDUAL SCREW REMAINED IN THE MAS VERTEX SCREW LOCKING DOWN THE ROD. SET SCREW WAS TIGHTENED USING THE TORQUE AND COUNTER TORQUE WRENCHES PROVIDED IN THE SET. BECAUSE THE ROD WAS SAFELY LOCKED INTO THE MAS, NO FURTHER STEPS WERE TAKEN. THE SET SCREW REMAINED IN THE PATIENT; HOWEVER THE FRAGMENTS WERE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300419 ↗
• MalfunctionFeb 27, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR CERVICAL FUSION AT C3-C6 DUE TO CENTRAL CANAL STENOSIS OF CERVICAL SPINE WITH PARALYSIS. INTRA-OP, SET SCREW SHEARED. THE MAS CROSS LINK WAS PLACED OVER THE MALE HEX POST AND WHILE PLACING THE MAS CROSSLINK LOCKING SET NUT, THE MALE HEX POST SHEARED OFF. THE RESIDUAL SCREW REMAINED IN THE MAS VERTEX SCREW LOCKING DOWN THE ROD. SET SCREW WAS TIGHTENED USING THE TORQUE AND COUNTER TORQUE WRENCHES PROVIDED IN THE SET. BECAUSE THE ROD WAS SAFELY LOCKED INTO THE MAS, NO FURTHER STEPS WERE TAKEN. THE SET SCREW REMAINED IN THE PATIENT; HOWEVER THE FRAGMENTS WERE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300413 ↗
• MalfunctionSep 7, 2017Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847554 ↗
• MalfunctionSep 1, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT C1-C2 FUSION PROCEDURE DUE TO C1-C2 FRACTURE. INTRA-OPERATIVELY THE HEAD OF THE EXTENSION CAP OF THE LOCKING SCREW SHEARED OFF. THE SET SCREW LOCKED IN SCREW HEAD AS INTENDED, BUT DURING THE FINAL TIGHTENING OF THE LAST LOCKING CAP, THE HEAD OF THE EXTENSION CAP SHEARED OFF. NO REVISION SURGERY WAS SCHEDULED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6837285 ↗