NA 04.613.716Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034737997), received between Sep 12, 2018 and Sep 30, 2019 — classified as 3 injuries.

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

• InjurySep 30, 2019Migration; Migration

  IT WAS REPORTED ON AN UNKNOWN DATE, AN UNKNOWN TOP SCREW WAS PARTIALLY PULLED OUT FROM THE VECTRA-ONE PLATE, AS SEEN VIA X-RAY. INITIALLY, THE PATIENT HAD AN ANTERIOR CERVICAL FUSION ON UNKNOWN DATE. THE PATIENT WAS CLINICALLY FINE. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. CONCOMITANT DEVICES REPORTED: VECTRA-ONE PLATE (PART# 04.613.176, LOT# UNKNOWN, QUANTITY 1). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/FIXED ANGLE 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9136315 ↗
• 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 4.0MM TI CERVICAL SELF-RETAINING SCREW SELF-DRILLING/FIXED ANGLE 16MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7869381 ↗
• 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 4.0MM TI CERVICAL SELF-RETAINING SCREW SELF-DRILLING/FIXED ANGLE 16MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7869203 ↗