SonicAnchor 1910-1273SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327096149), received between Mar 11, 2019 and Jun 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2024Activation Failure; Activation Failure

  SONIC ANCHORS FAILED TO "MELT" PROPERLY. THE FIRST ANCHOR ATTEMPTED TO MELT, BUT THE FOLLOWING TWO ANCHORS DID NOT MELT AT ALL. NO ERROR MESSAGE WAS DISPLAYED ON THE GENERATOR. AFTER THE FIRST TWO FAILED, WE DISCONNECTED THE MACHINE, ATTACHED A NEW TIP, THEN RECONNECTED THE MACHINE. NO ERROR MESSAGE DISPLAYED EITHER TIMES. THE SURGERY WAS COMPLETED IN AN OLD SCHOOL. NO ANCHORS WERE IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493056 ↗
• MalfunctionJun 7, 2024Activation Failure; Activation Failure

  SONIC ANCHORS FAILED TO "MELT" PROPERLY. THE FIRST ANCHOR ATTEMPTED TO MELT, BUT THE FOLLOWING TWO ANCHORS DID NOT MELT AT ALL. NO ERROR MESSAGE WAS DISPLAYED ON THE GENERATOR. AFTER THE FIRST TWO FAILED, WE DISCONNECTED THE MACHINE, ATTACHED A NEW TIP, THEN RECONNECTED THE MACHINE. NO ERROR MESSAGE DISPLAYED EITHER TIMES. THE SURGERY WAS COMPLETED IN AN OLD SCHOOL. NO ANCHORS WERE IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490085 ↗
• MalfunctionJun 7, 2024Activation Failure; Activation Failure

  SONIC ANCHORS FAILED TO "MELT" PROPERLY. THE FIRST ANCHOR ATTEMPTED TO MELT, BUT THE FOLLOWING TWO ANCHORS DID NOT MELT AT ALL. NO ERROR MESSAGE WAS DISPLAYED ON THE GENERATOR. AFTER THE FIRST TWO FAILED, WE DISCONNECTED THE MACHINE, ATTACHED A NEW TIP, THEN RECONNECTED THE MACHINE. NO ERROR MESSAGE DISPLAYED EITHER TIMES. THE SURGERY WAS COMPLETED IN AN OLD SCHOOL. NO ANCHORS WERE IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488148 ↗
• MalfunctionNov 19, 2019Difficult to Insert; Difficult to Insert

  SONIC ANCHOR (2) FAILED TO FIXATE. NEW IMPLANTS WERE USED WITH SUCCESSFUL FIXATION. SLIGHT DELAY IN COMPLETION OF THE PROCEDURE (5 MINUTES) AND EXTRA HOLES WERE DRILLED TO ACCOMMODATE NEW IMPLANTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345733 ↗
• MalfunctionMar 11, 2019Expiration Date Error

  IT WAS REPORTED THAT A DEVICE WITH AN EXPIRATION DATE OF 05 JANUARY 2019 WAS IMPLANTED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409356 ↗