NA 04.614.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034738642), received between Feb 13, 2018 and Jul 12, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (2 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. 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 6 most recent of 6 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: 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, C

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12154710 ↗
• 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12154643 ↗
• 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: 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, C

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12154580 ↗
• InjuryJul 8, 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, CERV

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12135644 ↗
• InjuryFeb 13, 2018Break; Break

  IT WAS REPORTED THE PATIENT HAD A C2-T1 POSTERIOR CERVICAL FUSION WITH SYNTHES SYNAPSE 3.5MM ROD SYSTEM IN (B)(6) 2015. THE SYNAPSE SCREWS WERE IN C2, C4, C6 AND T1 BILATERALLY. AT AN UNKNOWN POINT IN TIME, THE T1 SYNAPSE SCREWS BROKE BILATERALLY DUE TO NONUNION. THE SCREWS BROKE OFF JUST BELOW THE HEAD ON THE SYNAPSE SCREWS. ON (B)(6) 2018 A REVISION WAS PERFORMED TO ADDRESS THE NON UNION AND THE BROKEN SCREWS IN T1. FIRST THE LOCKING CAPS AND RODS WERE REMOVED. A DECISION WAS MADE TO USE THE SYNAPSE 4.0MM ROD SYSTEM WITH THE LARGER DIAMETER ROD. THEN ALL THE EXISTING SYNAPSE 3.5MM ROD SYSTEM SCREWS WERE REMOVED AND REPLACED WITH SYNAPSE 4.0 ROD SYTEM SCREWS (DID NOT REPLACE THE T1 SCREWS). THERE WERE NO HARDWARE RELATED ISSUES EXCEPT FOR THE TWO BROKEN T1 SCREWS. THE SURGEON WAS ABLE TO REMOVE ALL THE HARDWARE EXCEPT THE LEFT T1 BROKEN SCREW WHICH REMAINED IN THE PATIENT. HE WAS ABLE TO RETRIEVE THE RIGHT T1 BROKEN SCREW. NEW SYNAPSE 4.0MM ROD SYSTEM SCREWS WERE PLACED IN T2 AND T3. HE THEN CONTOURED NEW RODS AND SECURED THEM TO THE SCREWS WITH NEW SYNAPSE LOCKING CAPS. THE NEW CONSTRUCT IS FROM C2-T3. HE SUCCESSFULLY COMPLETED THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIU

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7267756 ↗
• InjuryFeb 13, 2018Break; Break

  IT WAS REPORTED THE PATIENT HAD A C2-T1 POSTERIOR CERVICAL FUSION WITH SYNTHES SYNAPSE 3.5MM ROD SYSTEM IN (B)(6) 2015. THE SYNAPSE SCREWS WERE IN C2, C4, C6 AND T1 BILATERALLY. AT AN UNKNOWN POINT IN TIME, THE T1 SYNAPSE SCREWS BROKE BILATERALLY DUE TO NONUNION. THE SCREWS BROKE OFF JUST BELOW THE HEAD ON THE SYNAPSE SCREWS. ON (B)(6) 2018 A REVISION WAS PERFORMED TO ADDRESS THE NON UNION AND THE BROKEN SCREWS IN T1. FIRST THE LOCKING CAPS AND RODS WERE REMOVED. A DECISION WAS MADE TO USE THE SYNAPSE 4.0MM ROD SYSTEM WITH THE LARGER DIAMETER ROD. THEN ALL THE EXISTING SYNAPSE 3.5MM ROD SYSTEM SCREWS WERE REMOVED AND REPLACED WITH SYNAPSE 4.0 ROD SYTEM SCREWS (DID NOT REPLACE THE T1 SCREWS). THERE WERE NO HARDWARE RELATED ISSUES EXCEPT FOR THE TWO BROKEN T1 SCREWS. THE SURGEON WAS ABLE TO REMOVE ALL THE HARDWARE EXCEPT THE LEFT T1 BROKEN SCREW WHICH REMAINED IN THE PATIENT. HE WAS ABLE TO RETRIEVE THE RIGHT T1 BROKEN SCREW. NEW SYNAPSE 4.0MM ROD SYSTEM SCREWS WERE PLACED IN T2 AND T3. HE THEN CONTOURED NEW RODS AND SECURED THEM TO THE SCREWS WITH NEW SYNAPSE LOCKING CAPS. THE NEW CONSTRUCT IS FROM C2-T3. HE SUCCESSFULLY COMPLETED THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIU

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7267733 ↗