GAMMA 3125-1180SRecalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 04546540375070), received between Aug 18, 2015 and Sep 29, 2026 — classified as 237 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (48 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. 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 25 most recent of 249 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture

  Patient problems: Fall; Limb Fracture

  MAUDE report 50934363 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "The patient presented to the hospital from home with increasing pain. No history of trauma was reported. X-ray examination demonstrated cut-out."This resulted in a revision surgery; total hip arthroplasty (THA).

  Patient problems: Pain; Perforation

  MAUDE report 50348972 ↗
• InjuryMar 20, 2026Positioning Failure

  AS REPORTED BY THE CUSTOMER: "WHEN INSERTING THE SHORT TITANIUM GAMMA NAIL, IT WAS IMPOSSIBLE TO LOCK IT IN PLACE STATICALLY DUE TO FRICTION ON THE NAIL; THEREFORE, IT HAD TO BE LOCKED DYNAMICALLY, RESULTING IN A HIGH RISK OF THE DISTAL SCREW BREAKING WHEN THE PATIENT PUT WEIGHT ON HER LEG. ON THE SAME NAIL, THE SLIDE FOR INSERTING THE CEPHALIC SCREW LOCKING SCREW BECAME MISALIGNED LEADING TO SLIPPAGE WHEN AIMING. THE SCREW ENDED UP IN THE PATIENT'S BUTTOCK AND COULD NOT BE REMOVED. A SECOND PROSTHESIS WAS OPENED AND PRESENTED THE SAME PROBLEM."UPDATE FEBRUARY 26, 2026WAS THE PROCEDURE COMPLETED SUCCESSFULLY? YES, BUT THE NAIL WAS STABILIZED DISTALLY IN A DYNAMIC POSITION. THE PATIENT REPORTS POSTOPERATIVE PAIN AT THE SCREW SITE.WAS THE PROCEDURE DELAYED? YES: 10 MINUTES OF ADDITIONAL OPERATING TIME.

  Patient problems: Pain; Perforation

  MAUDE report 24654239 ↗
• MalfunctionAug 15, 2025Mechanical Jam; Mechanical Jam

  THE END USER HAS REPORTED THAT DURING THE INTERVENTION WITH GAMMA3 SHORT, THE ROD GOT STUCK IN THE AIMING DEVICE AND THE DOCTOR COULD NO LONGER LOOSEN THE SCREW FIXING THE ROD IN THE AIMING SYSTEM. HAVING HAD 2 INSTRUMENTATIONS IN THE HOSPITAL TO BE ABLE TO SOLVE THE CASE, HE DECIDED TO TRY WITH THE OTHER INSTRUMENTATION, BLOCKING THE ROD HERE TOO. ALSO TO MENTION THAT THE DOCTOR HAS EXPERIENCE WITH GAMMA 3. FOLLOWING THIS EVENT, HE WAS FORCED TO USE ANOTHER SYSTEM FROM ANOTHER COMPANY. UPDATE ON AUGUST 1, 2025: THE SURGERY WAS PROLONGED 1 HOUR BECAUSE THE DOCTORS TRIED 2 KIT INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814907 ↗
• MalfunctionApr 29, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "BORE HOLE DISTAL LOCK DOES NOT LINE UP WITH AIMING SLEEVE. ANTI-ROTATION SCREW DOES NOT FIT." 4/1/2025 - ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP: "THE SURGEON TRIED TO INSERT THE SET SCREW BUT SAID THIS COULDN'T BE DONE. THE THREAD COULDN'T BE FOUND CORRECTLY. SECONDLY THE DISTAL HOLE WASN'T ALIGNED CORRECTLY WHEN DRILLING THROUGH THE SLEEVE. FINALLY THEY UNPACKED ANOTHER NAIL AND COMPLETED THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924659 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY SWTR IS A PROSPECTIVE, MULTI CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, REFRACTURE WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19954773 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19954349 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, MEDICAL DEVICE REMOVAL WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Insufficient Information

  MAUDE report 19953447 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19953312 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19953297 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY SWTR IS A PROSPECTIVE, MULTI CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, INFECTION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT

  Patient problems: Unspecified Infection

  MAUDE report 19953292 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19953214 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19953172 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, MAL-UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT

  Patient problems: Malunion of Bone

  MAUDE report 19952603 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19939517 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED WOUND HEALING WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19938794 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938620 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938619 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19938475 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, REFRACTURE WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19938471 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938466 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938323 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938316 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938312 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, IT WAS NOTED THAT PATIENT DIED. NOTE: PATIENT (ID (B)(6) DIED INTRA-OPERATIVELY AND IS CURRENTLY PART OF THE OVERDUE GROUP IN ALL VISITS. AS THE DATE OF DEATH IS UNKNOWN, IT COULD NOT BE DETERMINED, IF THE SURGERY WAS EVER FULLY COMPLETED AND THE DEATH OCCURRED A FEW DAYS AFTERWARDS OR THE PATIENT DIED IN THE OPERATING ROOM UPFRONT OF SURGERY COMPLETION.

  Patient problems: Insufficient Information

  MAUDE report 19938129 ↗