NA 04.614.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034738611), received between Oct 9, 2018 and Jul 8, 2021 — classified as 2 injuries, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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, C

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12135634 ↗
• MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  08/09/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE HEAD OF TITANIUM CANCELLOUS POLYAXIAL SCREW CAME OFF DURING CERVICAL FUSION. THERE WAS ANOTHER DEVICE USED TO COMPLETE THE PROCEDURE. THE BROKEN PIECE OF THE SCREW (THREADED PORTION) SUCCESSFULLY REMOVED. THERE WAS A SURGICAL DELAY WITH UNKNOWN NUMBER OF MINUTES. PROCEDURE OUTCOME IS SUCCESSFUL. PATIENT STATUS IS STABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8708207 ↗
• 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 SECOND ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE DUE TO CERVICAL STENOSIS WITH RADICULOPATHY, ADJACENT SEGMENT DEGENERATION, OSTEOPOROSIS AND SJOGRENS SYNDROME. THE PATIENT WAS IMPLANTED WITH ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 24MM, TWO (2) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREWS 14MM, ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 26MM, ONE (1) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREW 10MM, FIVE (5) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREWS 12MM , TEN (10) TITANIUM LOCKING SCREWS, TWO (2) TITANIUM CURVED RODS, AND ONE (1) UNKNOWN CONSTRUCTS: SYNAPSE. APPROXIMATELY FIVE (5) DAYS AFTER THE PROCEDURE, THE PATIENT NOTED THAT SHE BEGAN TO HAVE SKIN LESIONS LOCATED ON HER BACK, BILATERAL CLAVICLE REGION, NECK, FACE AND EARS. THE LESIONS WERE DESCRIBED AS LIKE SPIDER BITES THAT WERE TENDER, AND APPEARED AS PAPULES; BUT SHE DID NOT POP, DRAIN OR PICK AT THEM. THEY WOULD RESOLVE ON THEIR OWN; HOWEVER, NEW ONES DEVELOP DAILY. THE PATIENT INDICATED THAT THE SKIN ISSUE HAD BEEN ONGOING AND AFFECTING HER DAILY ACTIVITIES AND HAD BEEN UNDER THE CARE OF A DERMATOLOGIST. AN AQUANIL LOTION WAS USED TO TR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8479831 ↗
• MalfunctionOct 9, 2018Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2018, THE HEAD OF TITANIUM CANCELLOUS POLYAXIAL SCREW POPPED OUT THE SHANK OF THE SCREW WHILE TRYING TO ENGAGE THE SCREWDRIVER INTO THE SCREW. IT IS UNKNOWN IF WHEN THE EVENT OCCURRED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7947902 ↗