Perfix™ Iliac Screw System SL9510Recalls & reported problems
CG MedTech Co.,Ltd. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800015931816), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Fistula1
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Fracture
IN (B)(6) 2024, APPROXIMATELY 10 MONTHS AFTER THE INITIAL SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED WITH PAIN AND DISCOMFORT. X-RAY IMAGING CONFIRMED A FRACTURE OF THE ILIAC SCREW BODY, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE FRACTURED SCREW. THE PATIENT'S SYMPTOMS HAVE IMPROVED FOLLOWING THE REVISION PROCEDURE. ACCORDING TO THE PATIENT'S STATEMENT, PERSISTENT PAIN HAD BEEN PRESENT SINCE SCREW IMPLANTATION, AND THERE WAS PROLONGED HOSPITALIZATION DUE TO A FISTULA AND INFECTION. THE INVOLVED DEVICE WAS ILIAC SCREW - 9.5X100 MM (LOT NO. 14K294). REVIEW OF MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT COMPLIANT RAW MATERIAL WITHIN THE REQUIRED CHEMICAL COMPOSITION AND MECHANICAL PROPERTY SPECIFICATIONS WAS USED, AND THAT THE DEVICE GEOMETRY, DIMENSIONS, AND VISUAL APPEARANCE MET APPLICABLE SPECIFICATIONS.
Patient problems: Fistula; Implant Pain; Unspecified Infection
MAUDE report 24516065 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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