MAUDE Adverse Event Report: ACUMED, LLC ACU-LOC® 2 VDR PROX PLT, NARROW, R; PLATE, FIXATION, BONE

Model Number 70-0353

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.

Event Description

It was reported during the procedure, one of the threads of the screw started to come off when implanting into the plate.The procedure was completed without using the screw.There were no adverse consequences to the patient nor significant delay to the case.A new screw was opened to complete the procedure.This report is related to report number 3025141-2022-00227 for the screw involved in this event.

• Brand Name: ACU-LOC® 2 VDR PROX PLT, NARROW, R
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 15070816
• MDR Text Key: 304532414
• Report Number: 3025141-2022-00228
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Model Number: 70-0353
• Device Catalogue Number: 70-0353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 50 YR
• Patient Sex: Female