VERTEX® Reconstruction System 6958814Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 6958814 4.0 X 14MM MAS · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994354808), received between Jul 15, 2019 and Sep 24, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Nonstandard Device1
Patient problems
- Nerve Damage1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Nonstandard Device
Information was received from multiple sources (Healthcare professional, Distributor) regarding a Screw used for Pedicle screw fixation surgery with transforaminal lumbar interbody fusion therapy. It was reported that, prior to a pedicle screw fixation surgery with transforaminal lumbar interbody fusion, a Medtronic MAS screw was identified as having a screw head defect in which the distance between the two wings of the screw head was narrower than normal. It was reported that the inner set screw could not be inserted properly and the rod could not be securely locked in place. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878875 ↗InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED PER PATIENT CALL THAT ON UNKNOWN DATE, POST-OP, NERVE DAMAGE WAS REPORTED. HENCE, ON AN UNKNOWN DATE IN 2007, PATIENT UNDERWENT A REVISION SURGERY. AGAIN IN 2010, PATIENT UNDERWENT AN EMERGENCY REVISION SURGERY AS THE IMPLANTED SCREW LOOSENED. THE LOOSENED SCREW WAS REPLACED IN THIS REVISION SURGERY. REPORTEDLY, PATIENT CONTINUES TO EXPERIENCE PAIN AND MUSCLE TENSION.
Patient problems: Nerve Damage; Pain
MAUDE report 8790002 ↗
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- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.