NA 498.137Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034788982), received between Apr 3, 2019 and Nov 15, 2021 — classified as 13 injuries, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, ONE 3.5MM TITANIUM ROD AND ONE 3.5MM TITANIUM CURVED ROD WAS FOUND TO BE BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811528 ↗
• InjuryJul 13, 2021Patient Device Interaction Problem; Patient Device Interaction 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. THIS REPORT CAPTURES THE FOLLOWING COMPLICATIONS: DISPLACEMENT OF OTHER INTERNAL ORTHOPEDIC DEVICES, IMPLANTS (1): PATIENT NO (B)(6), MALE, (B)(6) WHO UNDERWENT ANTERIOR POSTERIOR CERVICAL TH ROD SPINAL 80MM 3.5MM AXON CUR READMITTED DUE TO DISPLACEMENT OF OTHER INTERNAL ORTHOPEDIC DEVICES, IMPLANTS. THIS REPORT IS FOR A POSTERIOR CERVICAL SYSTEMS (SYNAPSE) ROD. THIS IS REPORT 3 OF 8 FOR (B)(4). ADDITIONAL COMPLICATIONS FOR THIS CER ARE CAPTURED ON RELATED COMPLAINTS (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12160040 ↗
• 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: Intervertebral Disc Compression or Protrusion

  MAUDE report 12159055 ↗
• 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. STENO

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 12158419 ↗
• 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: Stenosis

  MAUDE report 12154597 ↗
• 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 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12144638 ↗
• 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 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: Bone Fracture(s)

  MAUDE report 12144333 ↗
• 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, C

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

  MAUDE report 12143323 ↗
• 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, CERVICOTHO

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 12139414 ↗
• 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 (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 (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 (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 (B)(6) FEMALE (B)(6) WHO UNDERWENT ANTERIOR/POSTERIOR CERVICAL FUSION WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE. STENOSIS, CERVICOTHORACIC SPINE (1) PATIENT (B)(6) FEMALE (B)(6) WHO UNDERWENT ANTERIOR L

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12135646 ↗
• 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 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. STEN

  Patient problems: Post Operative Wound Infection

  MAUDE report 12132104 ↗
• 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 (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 (B)(6) FEMALE, (B)(6) WHO UNDERWENT POSTERIOR CERVICOTHORACIC DECOMPRESSION FUSION WAS READMITTED FOR NEOPLASM, METASTATIC, BRAIN/SPINAL CORD. STENOSIS, CERVICAL SPINE (3). PATIENT (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 (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 (B)(6) FEMALE (B)(6) WHO UNDERWENT ANTERIOR/POSTERIOR CERVICAL FUSION WAS READMITTED DUE TO STENOSIS, CERVICAL SPINE. STENOSIS, CERVICOTHORACIC SPINE (1). PATIENT (B)(6) FEMALE (B)(6) WHO UNDERWENT ANTERIOR L

  Patient problems: Stenosis

  MAUDE report 12131306 ↗
• MalfunctionJan 4, 2021Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2020, ONE (1) 4.0MM TI CURVED ROD AND ONE (1) 3.5MM TI CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112066 ↗
• MalfunctionJun 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2020 THAT ON UNKNOWN DATE, TWO (2) 3.5MM TITANIUM CURVED RODS AND ONE (1) 3.5MM TITANIUM ROD WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163367 ↗
• MalfunctionJun 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2020 THAT ON UNKNOWN DATE, TWO (2) 3.5MM TITANIUM CURVED RODS AND ONE (1) 3.5MM TITANIUM ROD WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163348 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 4 240MM TITANIUM (TI) ROD, 1 500MM TITANIUM (TI) ROD, 3 80MM TITANIUM (TI) CURVED ROD, 1 500MM TITANIUM (TI) SOFT ROD AND 1 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163093 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162921 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162452 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE 3 6.0MM TITANIUM SOFT ROD 500MM, 5 3.5MM TITANIUM ROD 240MM, 1 3.5MM TITANIUM CURVED ROD 80MM, AND 1 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR 1 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 10160019 ↗
• InjuryApr 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  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.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8486940 ↗
• 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 8479873 ↗