D-RAD SMART PACKRecalls & reported problems across all models

We found 7 models of D-RAD SMART PACK by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2020 and Mar 31, 2023 — classified as 21 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (11 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

Most reported D-RAD SMART PACK problems

D-RAD SMART PACK models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• D-RAD SMART PACK 71158019

  PLATE, FIXATION, BONE
  10 reports
• D-RAD SMART PACK 71158022

  PLATE, FIXATION, BONE
  9 reports
• D-RAD SMART PACK 71158021

  PLATE, FIXATION, BONE
  7 reports
• D-RAD SMART PACK 71158020

  PLATE, FIXATION, BONE
  4 reports
• D-RAD SMART PACK 74682412

  PLATE, FIXATION, BONE
  1 report
• D-RAD SMART PACK 74682414

  PLATE, FIXATION, BONE
  1 report
• D-RAD SMART PACK 74692422

  PLATE, FIXATION, BONE
  1 report

Recent D-RAD SMART PACK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED SOME PAIN. AN ONSET DATE FOR THE REPORTED SYMPTOM IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. EVENTUALLY, THE PLATE WAS REMOVED AT THREE (3) YEARS POSTOPERATIVELY DUE TO PERSISTENT PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16656302 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED LIMITED PAIN, UNEXPECTED DECREASED RANGE OF MOTION, LIMITED FUNCTIONAL IMPAIRMENT AND EXTENSOR TENDON IRRITATION WHEN REVIEWED AT 12 MONTHS POST-OP. THE PATIENT WAS LISTED FOR PLATE REMOVAL BUT THE PATIENT CANCELLED THIS DUE TO LIFE STRESSORS AND HAS NOT RE-PRESENTED AT THE HEALTHCARE FACILITY. THE PATIENT ACHIEVED RADIOGRAPHIC UNION THREE (3) MONTHS POSTOPERATIVELY AND PARTIALLY RETURNED TO DUTY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain

  MAUDE report 16651201 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED A SUPERFICIAL WOUND INFECTION SIX (6) MONTHS POSTOPERATIVELY. THE PATIENT REQUIRED TREATMENT WITH IV FLUCLOXACILLIN FOR FOUR (4) DAYS BEFORE CONVERSION TO ORAL FLUCLOXACILLIN FOR FURTHER SEVEN (7) DAYS. THIS SYMPTOM WAS FULLY RESOLVED UPON TREATMENT. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE ONE (1) MONTH POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16650348 ↗
• InjuryMar 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN ORIF CASE, THE SURGEON WAS TIGHTENING A PEG INTO ONE OF THE D-RAD SMART PACK 4H RIGHT STANDARD PLATE LOCKING HOLES AND THE HEAD OF THE SCREW BROKE COMPLETELY THROUGH THE LOCKING TAB. THE SURGEON HAD TO REMOVE ANOTHER CORTICAL SCREW WHICH WAS ALREADY PLACED ALONG WITH PLATE TO ACCESS THE UNLOCKED SCREW AND REMOVE IT. THE SURGERY WAS THEN RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME PLATE. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620525 ↗
• InjuryOct 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED PAIN OVER PALPABLE PLATE THAT MADE NECESSARY THE REMOVAL OF THE PLATE. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TWENTY NINE (29) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Pain

  MAUDE report 15656522 ↗
• InjuryOct 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY THE PLATE REMOVAL, WASHOUT AND BRIDGING WITH AN EXTERNAL FIXATOR. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR (9) MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOM AND THE ADDITIONAL SURGERY PERFORMED WAS NOT PROVIDED. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE (4) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15656087 ↗
• InjuryOct 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED THE REMOVAL OF THE PLATE DUE TO PAIN. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TWENTY SIX (26) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED PAIN AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION AND WAS REPORTED AS "FULL RETURN TO DUTY" STATUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Implant Pain; Pain

  MAUDE report 15656084 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED AN UNPLANNED REVISION ON AN UNKNOWN DATE DUE TO NONUNION OF THE FRACTURE. THE PATIENT ACHIEVED A RADIOGRAPHIC UNION THREE (3) MONTHS POSTOPERATIVELY. ADDITIONAL DETAILS REGARDING THIS INTERVENTION AND THE PATIENT'S CURRENT HEALTH STATUS ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Malunion of Bone; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema

  MAUDE report 15636313 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ONE PATIENT WHO UNDERWENT AN INTERNAL FIXATION SURGERY ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM EXPERIENCED THE THUMB EXTENSOR TENDON (EPL) RUPTURE. IT IS UNKNOWN IF THIS INCIDENT OCCURRED INTRAOPERATIVELY OR POSTOPERATIVELY, AS WELL AS ANY MEASURES TAKEN TO RESOLVE THE COMPLICATION. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE TWO (2) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain; Rupture

  MAUDE report 15636293 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED NOTABLE PAIN, AN UNEXPECTED DECREASE IN RANGE OF MOTION OF THE WRIST AND A BONE COLLAPSE IN AN UNSPECIFIED REGION OF THE WRIST. A PLATE REMOVAL WAS REQUIRED TO TREAT THIS ADVERSE EVENT. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TWO (2) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS IS NOT KNOWN. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 2 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Necrosis; Pain

  MAUDE report 15636254 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED THE REMOVAL OF THE PLATE DUE TO PAIN. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR FIVE (5) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED PAIN AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Necrosis; Pain

  MAUDE report 15636199 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED PAIN THAT MADE NECESSARY THE REMOVAL OF THE PLATE. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TEN (10) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 2 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Impaired Healing; Inflammation; Pain

  MAUDE report 15636119 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED THE REMOVAL OF THE PLATE DUE TO CARPAL TUNNEL SYNDROME. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR EIGHT (8) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED COMPLICATION AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nerve Damage

  MAUDE report 15636078 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED THE RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON WHICH REQUIRED THE PLATE REMOVAL ON AN UNKNOWN DATE. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 15636028 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED THE NONUNION OF THE FRACTURE ALONG WITH PAIN AND AN UNEXPECTED DECREASE IN RANGE OF MOTION. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR EIGHT (8) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS IS NOT KNOWN. THE PATIENT'S OUTCOME, AS WELL AS ANY MEASURES TAKEN TO RESOLVE THESE COMPLICATIONS REMAIN UNKNOWN.

  Patient problems: Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15635943 ↗

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