D-RAD SMART PACK 71158021Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556364543), received between Aug 11, 2022 and Mar 31, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K132296, K210837, K213126); they may or may not involve this specific model.

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 16, 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.

• 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 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 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 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 ↗
• MalfunctionAug 11, 2022Corroded; Corroded

  IT WAS REPORTED THAT, WHILE SETTING UP FOR AN INTERNAL FIXATION, THE SCREWDRIVERS OF THE FOLLOWING PLATE KITS WERE NOTICED WITH RUST: D-RAD SMART PACK 4H LEFT STANDARD PLATE, D-RAD SMART PACK 4H LEFT WIDE PLATE, D-RAD SMART PACK 4H RIGHT STANDARD PLATE AND TWO D-RAD SMART PACK 4H RIGHT WIDE PLATES. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE SO SURGERY STARTED ON TIME. THE PATIENT WAS NOT AFFECTED BY THE FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132296, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2018 · Mar 7, 2018 · Terminated
  D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERI
• Z-1857-2017 · Mar 9, 2017 · Terminated
  D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM
• Z-1855-2017 · Mar 9, 2017 · Terminated
  D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
• Z-1856-2017 · Mar 9, 2017 · Terminated
  D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic