NA 04.614.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034738338), received between Dec 13, 2017 and Apr 5, 2019 — classified as 5 injuries.

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.

• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED COMPLAINT: 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 AND WAS IMPLANTED WITH ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 24MM, TWO (2) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREW 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 SCREW 12MM , TEN (10) TITANIUM LOCKING SCREW, TWO (2) TITANIUM CURVED ROD, AND ONE (1) UNKNOWN CONSTRUCTS: SYNAPSE. APPROXIMATELY FIVE (5) DAYS AFTER THE PROCEDURE, THE PATIENT NOTED THAT SHE BEGAN TO HAVE SKIN LESIONS LOCATED OVER HER BACK, BILATERAL CLAVICLE REGION, NECK, FACE AND EARS. THE LESIONS WERE DESCRIBED AS SPIDER BITES THAT WERE TENDER, AND APPEARED AS PAPULES BUT SHE DID NOT POP, DRAIN OR PICK AT THEM. THEY 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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8488527 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED COMPLAINT: 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 AND WAS IMPLANTED WITH ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 24MM, TWO (2) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREW 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 SCREW 12MM , TEN (10) TITANIUM LOCKING SCREW, TWO (2) TITANIUM CURVED ROD, AND ONE (1) UNKNOWN CONSTRUCTS: SYNAPSE. APPROXIMATELY FIVE (5) DAYS AFTER THE PROCEDURE, THE PATIENT NOTED THAT SHE BEGAN TO HAVE SKIN LESIONS LOCATED OVER HER BACK, BILATERAL CLAVICLE REGION, NECK, FACE AND EARS. THE LESIONS WERE DESCRIBED AS SPIDER BITES THAT WERE TENDER, AND APPEARED AS PAPULES BUT SHE DID NOT POP, DRAIN OR PICK AT THEM. THEY 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

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 8488524 ↗
• InjuryApr 5, 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 C3 TO T1 POSTERIOR INSTRUMENTED FUSION, C3 TO T1 POSTERIOR ARTHRODESIS, RIGHT-SIDED C6 AND C7 LAMINOFORAMINOTOMY AND MORSELIZED ILIAC CREST AUTOGRAFT THROUGH A SEPARATE INCISION DUE TO CERVICAL STENOSIS WITH RADICULOPATHY, ADJACENT SEGMENT DEGENERATION, OSTEOPOROSIS AND SJOGRENS SYNDROME. IT WAS FURTHER REPORTED THAT PATIENT HAD HARDWARE REMOVED ON AN UNKNOWN DATE AND PATIENT'S FACE, NECK AND UPPER CHEST/BACK CYSTIC LESIONS IMPROVED IMMEDIATELY. IT WAS ALSO REPORTED THAT PATIENT¿S MOLARS AT THE ANGLE OF JAW BILATERALLY DETERIORATED MARKEDLY AND REQUIRED EXTRACTION. ONE DIED AND WAS TOO FRIABLE TO DO A ROOT CANAL ON AND THE OTHER DETERIORATED AROUND ITS ROOT CANAL. BOTH HAD BEEN STABLE W/GOLD CROWNS PRIOR TO THE SPINAL SURGERY.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 8488521 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED COMPLAINT: 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 AND WAS IMPLANTED WITH ONE (1) 4.0MM TITANIUM CANCELLOUS POLYAXIAL SCREW 24MM, TWO (2) 3.5MM TITANIUM CANCELLOUS POLYAXIAL SCREW 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 SCREW 12MM , TEN (10) TITANIUM LOCKING SCREW, TWO (2) TITANIUM CURVED ROD, AND ONE (1) UNKNOWN CONSTRUCTS: SYNAPSE. APPROXIMATELY FIVE (5) DAYS AFTER THE PROCEDURE, THE PATIENT NOTED THAT SHE BEGAN TO HAVE SKIN LESIONS LOCATED OVER HER BACK, BILATERAL CLAVICLE REGION, NECK, FACE AND EARS. THE LESIONS WERE DESCRIBED AS SPIDER BITES THAT WERE TENDER, AND APPEARED AS PAPULES BUT SHE DID NOT POP, DRAIN OR PICK AT THEM. THEY 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

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 8488519 ↗
• 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 CANCELLOUS POLYAXIAL SCREW 12MM. THIS IS REPORT 8 OF 14 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7112873 ↗