MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 18MM; SCREW, FIXATION, BONE

Model Number LO-PRO LOCK SCRW,SS 3.5X 18MM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that 6-8 weeks after the initial implantation the device has come loose from the thread.A revision surgery had to be performed on the (b)(6) 2021.During the revision surgery the device was removed and the revision surgery was finished successfully with a longer clavicula plate.

• Brand Name: LO-PRO LOCK SCRW,SS 3.5X 18MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12196615
• MDR Text Key: 262500150
• Report Number: 1220246-2021-03404
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867047563
• UDI-Public: 00888867047563
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO LOCK SCRW,SS 3.5X 18MM
• Device Catalogue Number: AR-8835L-18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other