MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Based on the information available, the root cause could not be determined.

Event Description

In the article " operative treatment of distal radius fractures involving the volar rim-a systematic review of outcomes and complications." by lari.A., nouri, a., alherz, m., and prada, c., the study aimed to compare outcomes and assess the rates of complications and implant removal for different treatment methods of wrist fractures involving volar rim fractures (vrf).A systematic review of studies published in various databases was conducted to assess the operative outcomes of vrf.Twenty-six studies met the inclusion criteria with a total of 617 wrists.The most commonly used implants were 2.4 mm variable-angle volar rim plate from a competitor(17.5%), acu-loc 2 (acumed) (14%) and standalone hook plates (13%) (manufacturer unknown).Part number(s) of the acumed acu-loc 2 is unknown.The overall complication rate was 14% (n=87), with 44% (n=38) involving flexor tendon problems.The implant removal rate was 22%, with routine removal being performed in 54% and non-routine removal in 46% of cases.It is unknown how many patients were implanted with the acumed acu-loc 2.

• 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
• MDR Report Key: 16989873
• MDR Text Key: 315824531
• Report Number: 3025141-2023-00317
• 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: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/23/2023
• 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 Outcome(s): Other