Stratafix Spiral SXMD1B406Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031228030), received between Jun 22, 2023 and Nov 15, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER DISTRIBUTOR THE NEEDLE BROKE DURING THE SURGICAL PROCEDURE. THE BROKEN NEEDLE WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20695493 ↗
• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCESS OF CLOSING THE SURGICAL INCISION FASCIA LAYER AFTER SURGERY, THE NEEDLE BODY BROKE, AND THE BROKEN END OF THE NEEDLE BODY BOUNCED AND WAS UNABLE TO BE LOCATED. THE SUTURE SEWN ON THE FASCIA WAS STILL CONNECTED TO SOME OF THE NEEDLE BODY. THIS LEAD TO THE USE OF VARIOUS METHODS SUCH AS THE C-ARM DURING SURGERY TO LOCATE THE NEEDLE BODY, POSING A SIGNIFICANT RISK OF FOREIGN BODY RESIDUE DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19082310 ↗
• MalfunctionOct 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THERE WAS A PROBLEM WITH THE NEEDLE PULLING FREE FROM THE SUTURE DURING THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY, DELAY OR INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM OUR DISTRIBUTOR ON (B)(6) 2023 INDICATED DURING THE PROCESS OF REPAIRING A GASTRIC PERFORATION FOR THE PATIENT, THE NEEDLE BROKE IN THE PATIENT''S STOMACH. DUE TO TIMELY TREATMENT BY THE DOCTOR, THE REMAINING NEEDLE WAS COMPLETELY REMOVED FROM THE STOMACH WITHOUT INJURY OR DELAY."

  Patient problems: Foreign Body In Patient

  MAUDE report 17892728 ↗
• MalfunctionSep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR. DURING THE PROCESS OF REPAIRING A GASTRIC PERFORATION FOR THE PATIENT, THE NEEDLE BROKE IN THE PATIENT''S STOMACH. DUE TO TIMELY TREATMENT BY THE DOCTOR, THE REMAINING NEEDLE WAS COMPLETELY REMOVED FROM THE STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 17836004 ↗
• InjuryJun 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL AND COMPLETED THE RELEVANT AUXILIARY EXAMINATIONS, HE RECEIVED SURGERY. AFTER THE SURGERY, THE DOCTOR GAVE THE PATIENT ANTI INFECTION, DETUMESCENCE AND PAIN RELIEF, PREVENTION OF DEEP VEIN THROMBOSIS AND SYMPTOMATIC TREATMENT. AFTER THE SURGERY, THE WOUND DRESSING WAS STRENGTHENED. AFTER THE SURGERY, THE PATIENT'S DRESSING WAS REMOVED AND DRESSING WAS CHANGED, AND THE RED AND SWELLING OF THE LOWER PART OF THE RIGHT THIGH WERE SIGNIFICANTLY RELIEVED, AND THE TOUCH PAIN WAS LESS THAN BEFORE. THE SURGICAL OPENING OF THE FRONT SIDE OF THE RIGHT THIGH WAS RED, SWOLLEN, TENDER, AND A LITTLE OOZING. THE REST OF THE SURGICAL OPENING WAS NORMAL, THE PATIENT''S REJECTION AND ADVERSE REACTIONS TO SUTURE. CONTINUE TO PROVIDE PATIENTS WITH ANTI-INFECTION, SWELLING REDUCTION, PAIN RELIEF, AND SYMPTOMATIC SUPPORT TREATMENT, AND STRENGTHEN DRESSING CHANGES AT THE SURGICAL SITE.

  Patient problems: Granuloma

  MAUDE report 17184156 ↗