NA 04.614.220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034738819), received between Jul 24, 2017 and Jul 13, 2021 — classified as 4 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 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 12159927 ↗
• 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: Spinal Cord Injury

  MAUDE report 12153051 ↗
• 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: 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: Bone Fracture(s)

  MAUDE report 12147077 ↗
• 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. 686, 687,688, 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. 1165, 1166, 1167, 1168, 1169, 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. 1394, 1395, 1396, 1397) 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. 1398, 1399, 1400) 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. 1401, 1402, 1403, 1404, 1405) FEMALE (B)(6)-YEAR-OLD WHO UNDERWENT ANTERIOR/POSTERIOR CERV

  Patient problems: Spinal Cord Injury

  MAUDE report 12130089 ↗
• MalfunctionJul 24, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE POLY HEAD CAME OFF A 4.5MM SYNAPSE SCREW DURING A C3-T1 POSTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2017. THE SCREW HAD BEEN INSERTED; THE SURGEON WAS TRYING TO BACK IT OUT TO REPOSITION WHEN THE HEAD CAME OFF. THE SCREW WAS REMOVED; THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WAS A FIVE MINUTE SURGICAL DELAY TO OBTAIN ANOTHER SCREW TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS AS EXPECTED. IT WAS NOTED THAT THE SCREW HEAD POPPED OFF; THE SCREW AND THE HEAD ARE INTACT BUT SEPARATED. CONCOMITANT DEVICES REPORT: HANDLE (PART/LOT UNKNOWN, QUANTITY 1), HOLDING SLEEVE WITH THREAD (PART 03.614.017, LOT UNKNOWN, QUANTITY 1), HEXAGONAL SCREWDRIVER SHAFT, CROSS PINNED (PART 03.614.039, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6735379 ↗