VIPER 186789160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034132884), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT WAS IN AN ACCIDENT IN (B)(6) D AND TAKEN TO A (B)(6) TRAUMA CENTER FOR A T12 COMPRESSION FRACTURE. PATIENT WAS INSTRUMENTED PERCUTANEOUSLY FROM T10-L2 USING DSS VIPER SYSTEM LAST (B)(6) 2019. UPON RETURN TO THE US, PATIENT WAS BENDING AND HEARD / FELT A POP. HE CAME TO THE ER AND IMAGES REVEALED THE HARDWARE HAD DISASSEMBLED. SEVERAL SET SCREWS WERE DISPLACED AND THE ROD HAD COME OUT OF THE SCREW SADDLE. DURING THE REVISION SURGERY, ON (B)(6) 2019, IT WAS FOUND THAT ALL OF THE SET SCREWS WERE LOOSE AND SOME WERE SITTING EXTREMELY PROUD IN THE SCREW SADDLE. HARDWARE WAS REMOVED, REPLACED, AND SUFFICIENTLY LOCKED. THERE WAS A HARDWARE FAILURE AND INFECTION. THERE WAS A PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: VIPER2 STRAIGHT ROD-160 MM (PART # 186789160, LOT # UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180 MM (PART # 186789180, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9164294 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467