NA 04.614.126Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034738628), received between Apr 3, 2019 and Jul 9, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS UNDERGOING CERVICAL FUSION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: READMISSION: NEOPLASM, BENIGN, NOS (1): PATIENT NO. (B)(6), MALE, (B)(6) YEARS OLD WHO UNDERWENT POSTERIOR C3-T2 DECOMPRESSION FOR TUMOR RESECTION AND FUSION WITH SYNAPSE INSTRUMENTATION READMITTED FOR NEOPLASM, BENIGN, NOS. NEOPLASM, METASTATIC, BRAIN/SPINAL CORD (1): PATIENT NO. (B)(6), FEMALE, (B)(6)-YEAR-OLD WHO UNDERWENT POSTERIOR CERVICOTHORACIC DECOMPRESSION FUSION WAS READMITTED FOR NEOPLASM, METASTATIC, BRAIN/SPINAL CORD. STENOSIS, CERVICAL SPINE (3): PATIENT (NO. (B)(6)), FEMALE, (B)(6)-YEAR-OLD WHO UNDERWENT ANTERIOR C5-C6, C6-7 DISCECTOMY AND FUSION WITH ALLOGRAFT AND AVIATOR PLATE WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE. PATIENT (NO (B)(6)), FEMALE, (B)(6)-YEAR-OLD WHO UNDERWENT ANTERIOR C5-6, C6-7 DISCECTOMY AND FUSION WITH ALLOGRAFT AND AVIATOR PLATE WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE. PATIENT (NO. (B)(6)), FEMALE, (B)(6)-YEAR-OLD WHO UNDERWENT ANTERIOR/POSTERIOR CERVICAL FUSION WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12144786 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A C3 TO T1 POSTERIOR INSTRUMENTED FUSION, C3 TO T1 POSTERIOR ARTHRODESIS, RIGHT-SIDED C6 AND C7 LAMINOFORAMINOTOMY AND MORSELIZED ILIAC CREST AUTOGRAFT THROUGH A SEPARATE INCISION DUE TO CERVICAL STENOSIS WITH RADICULOPATHY, ADJACENT SEGMENT DEGENERATION, OSTEOPOROSIS AND SJOGRENS SYNDROME.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8479933 ↗