NA 498.125Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034788968), received between Dec 13, 2017 and Sep 23, 2022 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IMAGING EXAMS CONFIRMED A BROKEN ROD. PATIENT ORIGINALLY UNDERWENT SPINAL CORD DECOMPRESSION WITH CERVICAL SPINE ARTHRODESIS ON (B)(6) 2017, FOR SURGICAL TREATMENT OF BASILAR INTUSSUSCEPTION; POSTERIOR FOSSA CRANIECTOMY + OCCIPITAL CERVICAL FIXATION (ARNOLDCHIARI SYNDROME). POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN AND LETHARGY. THIS REPORT IS FOR AN UNKNOWN ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15469472 ↗
• 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) 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) 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) 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) 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) WHO UNDERWENT ANTERIOR/POSTERIOR CERVICAL FUSION WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE. STENOSIS, CERVICOTHORACIC SPINE (1): PATIENT (

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

  MAUDE report 12162979 ↗
• 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 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: Intervertebral Disc Compression or Protrusion

  MAUDE report 12139385 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 1 OF 10 FIR LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639785 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON DECEMBER 16, 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 1 OF 10 FIR LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639778 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 1 OF 1O FIR LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639750 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639743 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639725 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE 3.5MM TITANIUM ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9162859 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A C4-C6 POSTERIOR CERVICAL SPINAL FUSION ON (B)(6), 2016 WITH SYNTHES SYNAPSE. AT AN UNKNOWN POINT IN TIME, THE PATIENT DEVELOPED PAIN AND DEGENERATIVE DISC DISEASE BELOW THE C4-C6 FUSION. ON (B)(6) 2017 SURGEON PERFORMED THE REVISION PROCEDURE. DURING THE REVISION, SURGEON REMOVED THE EXISTING LOCKING CAPS (SIX) AND RODS (TWO). HE LEFT THE EXISTING SCREWS (SIX) IN PLACE FROM C4-C6. THERE WERE NO ISSUES WITH THE EXISTING HARDWARE. HE THEN PLACED TWO NEW SYNAPSE SCREWS AT T1 AND NEW RODS AND CONNECTED THEM. THE NEW CONSTRUCT IS C4-T1 WITH SYNTHES SYNAPSE 3.5MM ROD SYSTEM. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO PATIENT HARM. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS IS REPORT 14 OF 14 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7113402 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A C4-C6 POSTERIOR CERVICAL SPINAL FUSION ON (B)(6) 2016 WITH SYNTHES SYNAPSE. AT AN UNKNOWN POINT IN TIME, THE PATIENT DEVELOPED PAIN AND DEGENERATIVE DISC DISEASE BELOW THE C4-C6 FUSION. ON (B)(6) 2017 SURGEON PERFORMED THE REVISION PROCEDURE. DURING THE REVISION, SURGEON REMOVED THE EXISTING LOCKING CAPS (SIX) AND RODS (TWO). HE LEFT THE EXISTING SCREWS (SIX) IN PLACE FROM C4-C6. THERE WERE NO ISSUES WITH THE EXISTING HARDWARE. HE THEN PLACED TWO NEW SYNAPSE SCREWS AT T1 AND NEW RODS AND CONNECTED THEM. THE NEW CONSTRUCT IS C4-T1 WITH SYNTHES SYNAPSE 3.5MM ROD SYSTEM. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO PATIENT HARM. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7112390 ↗