STALIF C ABS1340Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815101029009), received between Feb 3, 2021 and Feb 3, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271975 ↗
• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271973 ↗
• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271972 ↗
• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271971 ↗
• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271969 ↗
• InjuryFeb 3, 2021Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT UNDERWENT SURGICAL INTERVENTION AND REMOVAL OF A 2-LEVEL STALIF C FLX AND STALIF C ABO SCREW CONSTRUCT AT C4/5 AND C5/6 DUE TO PSEUDOARTHROSIS (NON-UNION), SUBSIDENCE, SEGMENTAL KYPHOSIS, RADICULAR PAIN, AND OTHER UNINDICATED COMPLICATIONS. THE PATIENT HAD THE STALIF C FLX CONSTRUCT REPLACED WITH A CORTICAL RING AND ANTERIOR PLATE. THE REMOVAL WENT WELL AND GOOD SAGITTAL BALANCE WAS RESTORED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Malunion of Bone; Neck Pain; Pain

  MAUDE report 11271965 ↗