MAUDE Adverse Event Report: AUXEIN MEDICAL PRIVATE LIMITED AUXIN BRAND OF LOCKING PLATES/ BONE PLATE; PLATE, FIXATION, BONE

Model Number	PHEELOS - 3.5MM WISE-LOCK PROXIM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant is broken during the daily activity.Fda safety report id # (b)(4).

• Brand Name: AUXIN BRAND OF LOCKING PLATES/ BONE PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): AUXEIN MEDICAL PRIVATE LIMITED
• MDR Report Key: 9739869
• Report Number: MW5093189
• Device Sequence Number: 13999546
• Product Code: HRS
• UDI-Device Identifier: 08903993239179
• UDI-Public: 08903993239179
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PHEELOS - 3.5MM WISE-LOCK PROXIM
• Device Catalogue Number: A3-DND-QF-001-WF3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 35 YR
• Patient Weight: 65