MAUDE Adverse Event Report: ACUMED, LLC ACU-LOC 2 VDR PLATE PLATE, FIXATION, BONE

Model Number UNKNOWN

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/17/2022

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 information (model number, batch/lot number) is unknown.

Event Description

It was reported the removal instruments failed to remove the screws from the plate and from the bone after the plate was removed. Competitor devices were needed to successfully remove the hardware. This issue resulted in the procedure taking a few hours. This report is related to report numbers: 3025141-2022-00093, 3025141-2022-00094, 3025141-2022-00095, 3025141-2022-00096, 3025141-2022-00097, 3025141-2022-00098, 3025141-2022-00099, 3025141-2022-00100, 3025141-2022-00102, and 3025141-2022-00103 for the other devices involved in this event.

• Brand Name: ACU-LOC 2 VDR PLATE
• 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: 14190161
• MDR Text Key: 289965022
• Report Number: 3025141-2022-00101
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No