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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2020-00152: case 2.3025141-2020-00153: case 3.

Event Description

Case 1: patient was implanted with an acu-loc distal radius volar plating system to treat a distal radius fracture.At month 8 post op, the patient experienced sudden-onset loss of flexion at the interphalangeal joint of the thumb.During second surgery, fpl tendon rupture was identified and primary repair was performed and the plate was removed (as the fracture had achieved complete union).Article: evaluation of flexor pollicis longus tendon rupture after treatment of distal radius fracture with the volar plate.Kamil yamak; huseyin gokhan karahan; berrak karatan; cemil kayall; taskinn altay; j wrist surg 2020;9:219-224.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or ; 6279957138
• MDR Report Key: 10200444
• MDR Text Key: 196630282
• Report Number: 3025141-2020-00151
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2020

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: 06/15/2020
• Initial Date FDA Received: 06/26/2020
• 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): Required Intervention