VERTEX® Reconstruction System 6958734PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994356727), received between May 3, 2023 and May 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083071); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2023Malposition of Device; Malposition of Device

  CITATION: SHARON KA PO. TAM, PAOLO A. BOLOGNESE, ROGER W. KULA, ANDREW BRODBELT, MANSOOR FOROUGHI, MARAT AVSHALUMOV, DENMARK MUGUTSO AND ILENE RUHOY. SAFETY ANALYSIS AND COMPLICATIONS OF CONDYLAR SCREWS IN A SINGLE-SURGEON SERIES OF 250 OCCIPITOCERVICAL FUSIONS. A RETROSPECTIVE STUDY. ACTA NEUROCHIRURGICA (2022). 164:903¿911. DOI.ORG/10.1007/S00701-021-05039-Z. EVENT SUMMARY: A RETROSPECTIVE SAFETY AND COMPLICATION-BASED ANALYSIS OF OCCIPITOCERVICAL FUSION VIA CONDYLAR SCREWS FIXATION WAS PERFORMED. THIS STUDY AIMS TO EVALUATE THE SAFETY PROFILE AND COMPLICATIONS OF CONDYLAR SCREW FIXATION FOR OCCIPITOCERVICAL FUSION. A TOTAL OF 250 PATIENTS UNDERWENT OCCIPITOCERVICAL FUSIONS USING 500 CONDYLAR SCREWS BETWEEN SEPTEMBER 2012 AND SEPTEMBER 2018. TWO HUNDRED SEVENTEEN PATIENTS WERE FEMALES. THE MEAN AGE WAS 36 ± 13.4 SD, RANGING FROM 6 TO 75. 23 PATIENTS WERE BELOW 18 YEARS OF AGE (RANGING 6 TO 17). FORTY-FOUR CASES WERE REVISION SURGERIES FROM A FORMER BARPLATE CONFIGURATION. INDICATIONS FOR REVISION OPERATIONS INCLUDED PAINFUL PROFILE, METAL FATIGUE, OR BAR-PLATE BREAKDOWN, ALONE OR IN COMBINATION. ONE HUNDRED EIGHTY PATIENTS (72%) HAD A FORMAL DIAGNOSIS OR CLINICAL EVIDENCE. OF A C

  Patient problems: Nerve Damage

  MAUDE report 16858389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083071. One submission often covers many models, so check the product and lot details in each record.

• Z-1826-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.