VIPER 186727740Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034282664), received between Dec 4, 2018 and Mar 19, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS AN ISSUE WITH A SCREW. THE CORE OF THE SCREW WAS TWISTED. IT OCCURRED DURING THE PROCEDURE; THE INTERNAL TABS CAME APART, MAKING IT IMPOSSIBLE TO INSERT THE ROD. HOWEVER, THERE WAS NO ISSUE IN REMOVING THE SCREW AND REPLACING IT WITH ANOTHER ONE. THE PATIENT WAS REPORTED TO BE DOING WELL INITIALLY. SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE SCREW WAS TAKEN OFF, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644134 ↗
• InjuryJan 4, 2024Adverse 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 DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: POSTOPERATIVE INFECTION SUPERFICIAL. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED (MIS TI CFX FEN POLY 7X40 (B)(4)).

  Patient problems: Post Operative Wound Infection

  MAUDE report 18447192 ↗
• MalfunctionNov 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, TWO (2) POLYAXIAL SCREWS BROKE DURING FINAL INSERTION. THE SCREW HEADS DETACHED FROM THE SHAFTS. THE SCREWS WERE REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO REPLACEMENT SCREWS IN THE SAME POSITION WITHOUT ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728828 ↗
• InjuryDec 13, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9468836 ↗
• InjuryDec 13, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9468771 ↗
• InjuryMay 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8620995 ↗
• InjuryMay 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8620934 ↗
• InjuryDec 21, 2018Disconnection; Disconnection

  THE FOLLOWING WAS REPORTED: DEPUY 18-78. THE HEAD OF THE SCREW DISLOCATED DURING THE INSERTION. THE IMPLANT WAS REPLACED.

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

  MAUDE report 8189135 ↗
• MalfunctionDec 4, 2018Disconnection; Disconnection

  THE FOLLOWING WAS REPORTED: DETACHMENT OF THE HEAD OF THE SCREW FROM THE STEM, WHEN SCREWING IN THE SCREW WITH THE HELP OF THE SCREWDRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130088 ↗