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TAYLOR SPATIAL FRAME 71070369Recalls & reported problems

Smith & Nephew, Inc. · ILIZAROV DRILL TIP WIRE WITH STOPPER 1.8MM X 385MM · Class 2 · Implant

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556289044), received between Jun 27, 2019 and Jul 18, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information9

Patient problems

  • Injury9

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN (B)(6) HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802676 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN GLASGOW ROYAL INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802675 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN (B)(6) HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802674 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN (B)(6) INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802672 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN GLASGOW ROYAL INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802669 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN GLASGOW ROYAL INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802668 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN (B)(6) INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802665 ↗
  • InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN (B)(6) INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8802661 ↗
  • InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT TWO FRAME SURGEONS IN GLASGOW ROYAL INFIRMARY HAVE BOTH USED THE BAYONET STYLE WIRES AND REPORTED THAT DRILL TIPS ARE BLUNT AND IT TAKES MORE EFFORT TO PUSH THEM THROUGH THE BONE. ALSO, THE THREAD FILL UP WITH BONE. THEY WERE USED AND LEFT IN PATIENT UNTIL (B)(6) 2019, WHEN THE FRAME WAS REMOVED DUE TO A CONTINUED PIN SITE PROBLEM WHICH ALSO REQUIRED MULTIPLE DOSES OF ORAL ANTIBIOTICS.

    Patient problems: Injury

    MAUDE report 8742397 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.