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

Model Number 70-0357-S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

It was reported when inserting the locking screw, the screw did not fully seat into the plate, and a piece of metal emerged from the screw.The screw was disposed of by the hospital.It was also reported there were no adverse consequences to the patient.This report is related to report number 3025141-2022-00189 for the screw involved in this event.

Manufacturer Narrative

The results of the investigation were inconclusive since the device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.Based on the information received, the root cause of the reported event could not be determined.

• Brand Name: ACU-LOC® 2 VDR PLT STD 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: 14738879
• MDR Text Key: 298166034
• Report Number: 3025141-2022-00190
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0357-S
• Device Catalogue Number: 70-0357-S
• Device Lot Number: 535069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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 Race: Asian