MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. X-RING FIXATOR; EXTERNAL FIXATION DEVICE

Catalog Number	156-08011
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the polyaxial struts were assembled in a hexapod configuration.1 of the 6 struts was compressed by 5mm without compressing any of the other struts.The black collet separated from the blue strut body when compressing.A 2nd strut was compressed by 5mm causing the body to separate from the collet again.Although the strut body separated from the collet on 2 of the 6 struts, the struts were still stable and were adequate to leave as part of the frame assembly.There was no impact to patient, and there were no concerns regarding construct stability.

• Brand Name: X-RING FIXATOR
• Common Device Name: EXTERNAL FIXATION DEVICE
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 23417471
• Report Number: 3007289093-2025-00012
• Device Sequence Number: 21103424
• Product Code: KTT
• UDI-Device Identifier: 00842078136478
• UDI-Public: (01)00842078136478(10)257418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 156-08011
• Device Lot Number: 257418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Unknown