SPATIAL FRAMERecalls & reported problems across all models
Smith & Nephew, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 19 models of SPATIAL FRAME by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2017 and Feb 23, 2025 — classified as 26 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Break” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SPATIAL FRAME problems
Device problems
- Break31
- Device Markings/Labelling Problem22
- Material Deformation18
- Material Fragmentation17
- Inadequacy of Device Shape and/or Size9
- Adverse Event Without Identified Device or Use Problem6
- Naturally Worn5
- Corroded4
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- No Consequences Or Impact To Patient9
- Injury4
- Nonunion/Delayed-union Bone Fracture4
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
- Unspecified Infection2
- Bone Fracture(s)1
SPATIAL FRAME models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPATIAL FRAME 71070720PIN, FIXATION, THREADED15 reports
- SPATIAL FRAME 71070364APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT13 reports
- SPATIAL FRAME 71070710PIN, FIXATION, THREADED9 reports
- SPATIAL FRAME 71070705PIN, FIXATION, THREADED7 reports
- SPATIAL FRAME 71070200PIN, FIXATION, THREADED7 reports
- SPATIAL FRAME 71070220PIN, FIXATION, THREADED5 reports
- SPATIAL FRAME 71070114XAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- SPATIAL FRAME 71070410APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- SPATIAL FRAME 71070365CRUTCH3 reports
- SPATIAL FRAME 71070115XAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- SPATIAL FRAME 71070310PIN, FIXATION, THREADED2 reports
- SPATIAL FRAME 71070125PIN, FIXATION, THREADED2 reports
- SPATIAL FRAME 71070730PIN, FIXATION, THREADED2 reports
- SPATIAL FRAME 71071307XAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- SPATIAL FRAME 71070112XAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- SPATIAL FRAME 71070145PIN, FIXATION, THREADED1 report
- SPATIAL FRAME 71070205PIN, FIXATION, THREADED1 report
- SPATIAL FRAME 71070490TRAY, SURGICAL, INSTRUMENT1 report
- SPATIAL FRAME 71070111PIN, FIXATION, THREADED1 report
Recent SPATIAL FRAME adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, A PATIENT WITH A SIGNIFICANT BONE DEFECT ON RIGHT TIBIA UNDERWENT OSTEOTOMY AND BONE TRANSPORT TREATMENT WITH A TSF (TAYLOR SPATIAL FRAME) EXTERNAL FIXATOR ON (B)(6) 2022. FOLLOWING THIS PROCEDURE, THE PATIENT SUSTAINED RIGHT TIBIA NONUNION THAT REQUIRED REPAIR WITH AUTOGRAFT FROM THE RIGHT DISTAL FEMUR ON (B)(6) 2022. AT THAT MOMENT, THE PLAN WAS TO TAKE THE PATIENT BACK TO THE OR IN SIX WEEKS TO DEFINITELY REMOVE THE FRAME. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21442302 ↗InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED A LEFT ANKLE CHRONIC INFECTION AFTER PLACEMENT OF A COMPETITORS EXTERNAL FIXATOR ON (B)(6) 2019. HE UNDERWENT TAYLOR SPATIAL FRAME (TSF) EXTERNAL FIXATOR PLACEMENT WITH I&D AND ANTIBIOTIC THERAPY INITIATION. FOLLOWING THIS PROCEDURE, THE PATIENT RETURNED TO THE OR ON (B)(6) 2020 FOR REMOVAL OF THE TSF FIXATOR, WITH I&D AND ANTIBIOTIC BEADS PLACEMENT DUE TO SEPTIC NONUNION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21441845 ↗InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING A TAYLOR SPATIAL FRAME (TSF) PLACEMENT ON (B)(6) 2018 WITH I&D, REMOVAL OF ANTIBIOTIC BEADS, AUTOGRAFT HARVEST FROM RIGHT FEMUR AND BONE GRAFTING DUE TO SUSTAINED RIGHT PILON NONUNION, THE PATIENT REQUIRED A RE-REVISION SURGERY ON (B)(6) 2018 DUE TO PERSISTENT RIGHT PILON NONUNION. THE TSF FIXATOR WAS REMOVED DURING THIS PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21441843 ↗InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING A TAYLOR SPATIAL FRAME (TSF) EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2018 AS PART OF AN EXTERNAL FIXATION REVISION SURGERY DUE TO INFECTION IN THE CALCANEAL PINS, THE PATIENT SUSTAINED NONUNION OF THE RIGHT TIBIA FRACTURE AND PERSISTENT DRAINING WOUND WITH SUSPECTED OSTEOMYELITIS IN OR AROUND (B)(6) 2018. IT IS UNKNOWN IF THE FRAME WAS REMOVED AND THE RLE AMPUTATED AS PER SURGEON'S RECOMMENDATION GIVEN THE PATIENT'S COMORBIDITIES AND RISK FOR SEPSIS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Fluid Discharge; Nonunion/Delayed-union Bone Fracture
MAUDE report 21441816 ↗MalfunctionMar 14, 2022Break; Break
IT WAS REPORTED THAT THE STRUTS OF THE FAST FX STRUT FOR TSF LNG WERE STUCK AND DID NOT MOVE. THEY DO NOT MOVE PROPERLY. THE MECHANISM WAS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13758946 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT THE EQUATOR CLAMP BROKE IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625561 ↗MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT, DURING A TAYLOR FIXATION SURGERY, THE FAST FX STRUT FOR TSF MED BROKE WHILE TIGHTENING. ALL THE BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13505700 ↗MalfunctionFeb 9, 2022Break; Break
IT WAS REPORTED THAT THE EQUATOR CLAMP WAS BROKEN. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500032 ↗MalfunctionNov 25, 2021Break; Break
IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, THE SHOULDER BOLTS OF A FAST FX STRUT FOR TSF MED AND FAST FX STRUT FOR TSF SHT WERE TIGHTENED BY HAND AND COULD THEN ONLY BE RELEASED WITH A WRENCH. BOTH THREADS WERE BROKEN AS A RESULT. THE SHOULDER BOLT ON THE FAST FX STRUT FOR TSF MED EVEN BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12874546 ↗MalfunctionNov 25, 2021Break; Break
IT WAS REPORTED THAT, THE SHOULDER BOLTS OF A FAST FX STRUT FOR TSF MED AND FAST FX STRUT FOR TSF SHT WERE TIGHTENED BY HAND AND COULD THEN ONLY BE RELEASED WITH A WRENCH. BOTH THREADS WERE BROKEN AS A RESULT. THE SHOULDER BOLT ON THE FAST FX STRUT FOR TSF MED EVEN BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12874512 ↗MalfunctionNov 17, 2021Break; Solder Joint Fracture; Break; Solder Joint Fracture
IT WAS REPORTED THAT A EQUATOR CLAMP WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12830783 ↗MalfunctionAug 9, 2021Break; Break
IT WAS REPORTED THAT A WIRE CUTTER HAVE WEAR AND DAMAGE AND A EQUATOR CLAMP IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12297599 ↗MalfunctionJul 13, 2021Break; Break
IT WAS REPORTED THAT AN EQUATOR CLAMP WAS FOUND TO BE BROKEN INSIDE THE PACKAGE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12159254 ↗MalfunctionJun 30, 2021Peeled/Delaminated; Mechanics Altered; Peeled/Delaminated; Mechanics Altered
IT WAS REPORTED THAT, THE PAINT OF THE FAST FX STRUT FOR TSF SHT WAS CHIPPING AND THE DEVICE WAS NOT EXTENDING PROPERLY. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND IF THERE WAS A PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12096835 ↗MalfunctionJun 23, 2021Break; Break
IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, THE KNOB TO TIGHTEN AN EQUATOR CLAMP BROKE OFF WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12053811 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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