MAUDE Adverse Event Report: ORTHOHELIX SURGICAL DESIGNS, INC. MINI MAXLOCK EXTREME; NONE

Catalog Number MXM-002-6P

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Mini maxlock extreme 6-hole ortholink (mxm-002-6p) broke 6 weeks post-op.Pt was put in a fracture boot post-op.Pt was not supposed to be walking on it, but did.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

• Brand Name: MINI MAXLOCK EXTREME
• Type of Device: NONE
• Manufacturer (Section D): ORTHOHELIX SURGICAL DESIGNS, INC.; medina OH
• Manufacturer Contact: 1065 medina, rd., suite 500; medina, OH 44256 ; 3308699562
• MDR Report Key: 3993445
• MDR Text Key: 18925487
• Report Number: 3005039508-2014-00010
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K101962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 07/25/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MXM-002-6P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1