BENGAL 187301205Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034137094), received between Nov 19, 2018 and Jun 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING ANTERIOR CERVICAL FUSION SURGERY, THE SURGEON TRIALED AND IMPLANTED THE BENGAL CAGE IN THE C4-5-DISC SPACE. HE WANTED TO REVISE THE POSITION OF THE IMPLANT BY PULLING THE IMPLANT BACK (ANTERIORLY) BY A FEW MMS. HE ATTEMPTED TO REATTACH THE INSERTER HOWEVER THE THREADS ON THE CAGE APPEARED TO BE STRIPPED AND THE INSERTER STYLET WOULD NOT TIGHTEN TO THE CAGE. HE USED AN UP-GOING CURETTE TO REMOVE THE IMPLANT. WE RETRIEVED A NEW IMPLANT AND FINISHED THE CASE WITH SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

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

  MAUDE report 10159283 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING THE IMPLANTATION OF A 5MM LARGE BENGAL CERVICAL SPACER A FLAT TAMP WAS TURNED ON THE EDGE AND IMPACTED WITH A MALLET SHATTERING THE IMPLANT. THE SURGEON WAS ATTEMPTING TO POSITION THE IMPLANT FLUSH WITH THE VERTEBRAL BODY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: UNKNOWN IMPACTION INSTRUMENTS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE BENGAL IMPLANT LRG 5MM 7 DEG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566104 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THE SURGEON WAS IMPACTING THE CAGE AND THE DEVICE BROKE INTO FOUR PIECES. THE DEVICE WAS BEING IMPACTED WITH A NYLON MALLET. THE AMOUNT OF FORCE BEING USED WAS VERY LITTLE. SURGICAL DELAY OF 5 MINUTES WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085995 ↗