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.