VIPER 186760140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034465456), received between Jul 12, 2018 and Jul 28, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 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 28, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021 DUE TO SCREW HEAD COME OFF. ORIGINALLY, THE PATIENT HAD PRIMARY SPINAL FUSION AT 3A-3B (TREATING THORACIC MYELOPATHY AFTER DECOMPRESSION) ON (B)(6) 2021. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS REPORT IS 2 OF 4 FOR (B)(4).

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

  MAUDE report 12242815 ↗
• InjuryJul 28, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021 DUE TO SCREW HEAD COME OFF. ORIGINALLY, THE PATIENT HAD PRIMARY SPINAL FUSION AT 3A-3B (TREATING THORACIC MYELOPATHY AFTER DECOMPRESSION) ON (B)(6) 2021. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS REPORT IS 3 OF 4 FOR (B)(4).

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

  MAUDE report 12242713 ↗
• InjuryJul 28, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021 DUE TO SCREW HEAD COME OFF. ORIGINALLY, THE PATIENT HAD PRIMARY SPINAL FUSION AT 3A-3B (TREATING THORACIC MYELOPATHY AFTER DECOMPRESSION) ON (B)(6) 2021. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS REPORT IS 4 OF 4 FOR (B)(4).

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

  MAUDE report 12242712 ↗
• InjuryJul 28, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021 DUE TO SCREW HEAD COME OFF. ORIGINALLY, THE PATIENT HAD PRIMARY SPINAL FUSION AT 3A-3B (TREATING THORACIC MYELOPATHY AFTER DECOMPRESSION) ON (B)(6) 2021. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS REPORT IS 1 OF 4 FOR (B)(4).

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

  MAUDE report 12242708 ↗
• MalfunctionFeb 17, 2021Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A POSTERIOR SPINAL FUSION TREATING THE TWELFTH THORACIC CENTRUM FRACTURE. DURING THE SURGERY, IT WAS NOTICED THAT AFTER THE SCREW FINALLY FIXATED, THE SCREW HAD CUT OUT INWARD. ALSO, IT WAS FOUND THAT THE SCREW AT L1 LEFT HAD BACKED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY LESS THAN 30-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340359 ↗
• InjuryJul 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, THE TLIF SURGERY WAS PERFORMED BY USING THE EXPEDIUM VIPER II SYSTEM. THE FIXED AREA WAS L5 - S1. AFTER THE SURGERY, IT WAS FOUND UNDER THE X-RAY THAT PART OF THE BROKEN TAB OF CORTICAL FIX X-TAB (186760140) AT S1 HAD BEEN LEFT IN THE PATIENT¿S BODY. IT IS NOT CLEAR WHEN THE HOSPITAL NOTICED THIS EVENT. THE SURGEON COMMENTS AS FOLLOWS. NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN CONFIRMED AFTER THE SURGERY THE PATIENT IS POSTOPERATIVELY IN A GOOD CONDITION BECAUSE HIS/HER PREOPERATIVE PARALYSIS HAS BEEN IMPROVED AND THE PAIN AS WELL HAS COMPLETELY GONE AWAY. NO OPERATION TO REMOVE THE PART OF THE BROKEN TAB IS REQUIRED.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7682410 ↗