SuperCable® Iso-Elastic™ Cerclage System 37-100-1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00898142001975), received between Feb 15, 2016 and Feb 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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

• InjuryFeb 15, 2016Off-Label Use; Off-Label Use

  ON (B)(6) 2015, A PEDIATRIC PLASTIC SURGEON IN JAPAN PERFORMED A PROCEDURE TO CORRECT A "PIGEON CHEST" DEFORMITY USING WHAT WAS DESCRIBED AS A TYPE OF NUSS TECHNIQUE. IN THIS PROCEDURE, THE SURGEON USED 1.0MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS (PART NUMBER 37-100-1010) TO SECURE A BIOMET PECTUS BAR TO THE RIBS. THE ENDS OF EACH SUPERCABLE IMPLANT WERE THREADED THROUGH A SINGLE HOLE ON EITHER SIDE OF THE PECTUS BAR IMPLANT. ON (B)(6) 2015, THE SURGEON DETERMINED THAT THE CABLE OF ONE OF THE 1.0MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS WAS SEVERED. THE SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2016 WHERE THE 1.0MM CABLE WAS EXPLANTED AND REPLACED WITH A 1.5MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANT (PART NUMBER 35-100-1010). THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016.

  Patient problems: Injury

  MAUDE report 5436849 ↗