SuperCable® Iso-Elastic™ Cerclage System 35-100-1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00898142001357), received between May 17, 2017 and Oct 15, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2019Use of Device Problem; Use of Device Problem

  ON 09/16/2019, A US SALES REPRESENTATIVE REPORTED THAT AN ORTHOPEDIC TRAUMA SURGEON HAD CONCERNS WITH THE 1.5 MM SUPER CABLE ISO-ELASTIC CERCLAGE IMPLANT. THE SURGEON WAS CONTACTED AND REPORTED A FEW FEMUR FRACTURE CASES INVOLVING SUB-TROCHANTERIC NAIL (BRAND/MANUFACTURER NOT REPORTED) FIXATION IN WHICH THE FRACTURE HAD HEALED AS EXPECTED AND PATIENT WAS DOING FINE THROUGH THE HEALING PERIOD, BUT 1-2 YEARS LATER PRESENTED WITH A "BONE REACTION" (WHICH HE DESCRIBED AS DELAYED SCALLOPING OF THE BONE AROUND/UNDER THE CABLES, SOME WITH INFECTION). IN THESE CASES, THE HARDWARE WAS EXPLANTED AND THE SITUATION RESOLVED. THE EXPLANTED CABLES WERE NOT SAVED. THE SURGEON ALSO STATED THAT HE HAS OBSERVED CONTINUING CALLUS FORMATION AROUND THE CABLES. THE SURGEON DID NOT REPORT THE EXACT NUMBER OF CASES OR OTHER REQUESTED INQUIRY DETAILS. THIS REPORT IS FOR THESE REPORTED EVENTS BECAUSE THE NUMBER OF PATIENTS INVOLVED IS UNKNOWN AT THIS TIME. THE SURGEON INDICATED THAT HE ALWAYS TENSIONS THE CABLE TO AT LEAST THE HI MARK AND OFTEN GOES PAST HI WITH A GOAL OF MAXIMIZING CABLE TENSION, AND THAT THESE PATIENTS HAD A MIXTURE OF FEMUR BONE QUALITY. THE SURGEON STATED THAT OVER-COMPRESSION FROM HIS

  Patient problems: Injury; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 9192090 ↗
• InjuryFeb 25, 2019Use of Device Problem; Use of Device Problem

  ON 01/30/2019, AN (B)(4) DISTRIBUTOR REPORTED THAT A CARDIOTHORACIC SURGEON THERE REPORTED INSTANCES OF STERNAL DEHISCENCE IN STERNOTOMY CLOSURE PATIENTS. THE DISTRIBUTOR STATED THAT THE NUMBER OF DEHISCENCES, THEIR POST-OPERATIVE TIMING, AND OTHER REQUESTED INQUIRY DETAILS WERE NOT REPORTED BY THE SURGEON. THIS REPORT IS FOR THESE REPORTED EVENTS BECAUSE THE NUMBER OF PATIENTS INVOLVED IS UNKNOWN AT THIS TIME. THE DISTRIBUTOR REPORTED THAT THE SURGEON WAS IN THE PRACTICE OF USING THREE OR FOUR 1.5MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS (PART NUMBER 35-100-1010 OR 35-100-1040) PER PATIENT FOR STERNOTOMY CLOSURE WITH NO ADDITIONAL WIRE OR OTHER FIXATION OF THE STERNUM. THE DISTRIBUTOR FURTHER REPORTED THAT THE SURGEON ALWAYS TENSIONED THE CABLES TO THE LOW SETTING ON THE TENSIONING INSTRUMENT AND THAT THESE PATIENTS HAD A MIXTURE OF STERNAL BONE QUALITY. AT THE RE-CLOSURE SURGERIES, THE CABLES WERE FOUND TO BE INTACT AND HAD CUT INTO THE BONE, AND THEY WERE EXPLANTED BUT NOT SAVED. THE SURGEON THEN USED "O-PDS" (SURGICAL SUTURE) TO CLOSE THE STERNUM. THE FINAL OUTCOME AND DISCHARGE DATE WAS NOT PROVIDED.

  Patient problems: Injury; Patient Problem/Medical Problem; Wound Dehiscence

  MAUDE report 8367493 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A CARDIOTHORACIC SURGEON IN (B)(6) PERFORMED STERNOTOMY CLOSURE ON A PATIENT WITH OBESITY AND POOR BONE QUALITY USING FOUR SUPERCABLE CERCLAGE CABLE IMPLANTS (PART NUMBER 35-100-1010) AND ONE MONOFILAMENT METAL WIRE MADE BY ANOTHER MANUFACTURER. THE SECOND DAY AFTER SURGERY, THE MONOFILAMENT WIRE AND ONE CABLE WERE FOUND BROKEN, WITH THREE CABLES HAVING CUT-THROUGH THE STERNUM BONE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 IN WHICH THE SUPERCABLES WERE EXPLANTED AND THE STERNOTOMY WAS RE-CLOSED. THE OUTCOME OF THE REVISION SURGERY AND THE DISCHARGE DATE HAVE BEEN REQUESTED.

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 7189718 ↗
• InjuryDec 21, 2017Device Issue; Device Handling Problem; Device Issue; Device Handling Problem

  ON 11/26/2017, AN (B)(4) DISTRIBUTOR REPORTED THAT A CARDIOTHORACIC SURGEON HAD THREE STERNOTOMY CLOSURE PATIENTS THAT PRESENTED WITH SYMPTOMS OF INFLAMMATION AND IRRITATION AROUND THE SURGICAL SITE BETWEEN THREE AND SIX MONTHS POST-OP. THIS REPORT IS FOR THE SECOND PATIENT. THE SURGEON USED SEVERAL 1.5MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS (PART NUMBER 35-100-1010) TO CLOSE THE STERNOTOMY. ONLY ONE IMPLANT PRESENTED WITH THE REPORTED SYMPTOMS. NO SAMPLES WERE COLLECTED TO CONFIRM AN INFECTION, AND THERE WAS NO REPORT OF ANTIBIOTICS PRESCRIBED. AFTER THE IMPLANT WAS EXPLANTED, THE CONDITION WAS RESOLVED. THE FINAL DISCHARGE DATE WAS NOT PROVIDED. IT IS UNKNOWN IF THE EXPLANTED IMPLANT WAS REPLACED WITH ANOTHER TYPE OF STERNOTOMY FIXATION.

  Patient problems: Inflammation

  MAUDE report 7141411 ↗
• InjuryDec 21, 2017Device Issue; Device Handling Problem; Device Issue; Device Handling Problem

  ON (B)(4) 2017, (B)(4) DISTRIBUTOR REPORTED THAT A CARDIOTHORACIC SURGEON HAD THREE STERNOTOMY CLOSURE PATIENTS THAT PRESENTED WITH SYMPTOMS OF INFLAMMATION AND IRRITATION AROUND THE SURGICAL SITE BETWEEN THREE AND SIX MONTHS POST-OP. THIS REPORT IS FOR THE THIRD PATIENT. THE SURGEON USED SEVERAL 1.5MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS (PART NUMBER 35-100-1010) TO CLOSE THE STERNOTOMY. ONLY ONE IMPLANT PRESENTED WITH THE REPORTED SYMPTOMS. NO SAMPLES WERE COLLECTED TO CONFIRM AN INFECTION, AND THERE WAS NO REPORT OF ANTIBIOTICS PRESCRIBED. AFTER THE IMPLANT WAS EXPLANTED, THE CONDITION WAS RESOLVED. THE FINAL DISCHARGE DATE WAS NOT PROVIDED. IT IS UNKNOWN IF THE EXPLANTED IMPLANT WAS REPLACED WITH ANOTHER TYPE OF STERNOTOMY FIXATION.

  Patient problems: Inflammation

  MAUDE report 7141410 ↗
• InjuryDec 21, 2017Device Issue; Device Handling Problem; Device Issue; Device Handling Problem

  ON (B)(6) 2017, AN (B)(4) DISTRIBUTOR REPORTED THAT A CARDIOTHORACIC SURGEON HAD THREE STERNOTOMY CLOSURE PATIENTS THAT PRESENTED WITH SYMPTOMS OF INFLAMMATION AND IRRITATION AROUND THE SURGICAL SITE BETWEEN THREE AND SIX MONTHS POST-OP. THIS REPORT IS FOR THE FIRST PATIENT. THE SURGEON USED SEVERAL 1.5 MM SUPERCABLE ISO-ELASTIC CERCLAGE IMPLANTS (PART NUMBER 35-100-1010) TO CLOSE THE STERNOTOMY. ONLY ONE IMPLANT PRESENTED WITH THE REPORTED SYMPTOMS. NO SAMPLES WERE COLLECTED TO CONFIRM AN INFECTION, AND THERE WAS NO REPORT OF ANTIBIOTICS PRESCRIBED. AFTER THE IMPLANT WAS EXPLANTED, THE CONDITION WAS RESOLVED. THE FINAL DISCHARGE DATE WAS NOT PROVIDED. IT IS UNKNOWN IF THE EXPLANTED IMPLANT WAS REPLACED WITH ANOTHER TYPE OF STERNOTOMY FIXATION. .

  Patient problems: Inflammation

  MAUDE report 7141407 ↗
• InjuryMay 17, 2017Contamination; Microbial Contamination of Device; Device Handling Problem; Contamination; Microbial Contamination of Device; Device Handling Problem

  ON (B)(6) 2017, A CARDIOTHORACIC SURGEON IN (B)(6) PERFORMED STERNOTOMY CLOSURE USING FIVE (1.5MM DIAMETER) SUPERCABLE CERCLAGE IMPLANTS (PART NUMBER 35-100-1010). THE SURGEON INFORMED THE SALES AGENT THAT THE PATIENT DEVELOPED ACUTE MEDIASTINITIS AND THAT A RE-DO/REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 IN WHICH THE SUPERCABLES WERE EXPLANTED AND THE STERNOTOMY WAS CLOSED USING ANOTHER COMPANY'S CERCLAGE SYSTEM. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS REPORTED TO BE DOING WELL. THE DISCHARGE DATE HAS BEEN REQUESTED.

  Patient problems: Bacterial Infection; Injury

  MAUDE report 6571999 ↗