VERTEX® Reconstruction System 6958712Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 6958712 3.5 X 12MM MAS · Class 2 · Implant
All models of VERTEX Reconstruction System (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994355058), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Nerve Damage1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 THAT ON: (B)(6) 2003: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: HERNIATED CERVICAL DISK; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C5 WITH ALLOGRAFT BONE AND REFLEX PLATE. PRODUCTS MANUFACTURED BY ALLOSOURCE WERE IMPLANTED IN THIS SURGERY. (B)(6) 2007: THE PATIENT UNDERWENT A SURGERY. ALL THE IMPLANTS FROM ANOTHER MANUFACTURER WERE USED IN THIS SURGERY. (B)(6) 2010: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: CERVICAL PSEUDOARTHROSIS. IMAGING STUDIES REVEALED THE PRESENCE OF PSEUDOARTHROSIS WITH LUCENECY AROUND HER SCREWS AND A PAUCITY OF INTERBODY SUPPORT. SHE UNDERWENT POSTERIOR CERVICAL FUSION AT C3-C6 USING SEGMENTAL INSTRUMENTATION, ARTHRODESIS AT C3-C6, USE OF BONE MORPHOGENIC PROTEIN (BMP) AND ALLOGRAFT, USE OF NEUROMONITORING AND USE OF C-ARM.
Patient problems: Nerve Damage; Pain
MAUDE report 8789989 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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