NA 04.615.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034739809), received between Jun 22, 2020 and Jul 12, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 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. STENOS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12153564 ↗
• InjuryJul 7, 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: 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. STENOSIS, CERVIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12130051 ↗
• InjuryJun 22, 2020Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10179303 ↗