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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Deformity/ Disfigurement (2360)

Event Type  malfunction  

Manufacturer Narrative

Additional cases associated with this article: 3025141-2020-00158: case 1.

Event Description

Article: dorsal wrist spanning plate fixation for treatment of radiocarpal fracture-dislocations; wahl, elizabeth\ p.; lauder, alexander s.; pidgeon, tyler s., guerrero, evan m.; ruch, david s.; and richard, marc j; american association for hand surgery; 2019.Case 2: patient with wrist spanning plate developed recurrent carpal tunnel syndrome and persistent dislocation and angular deformity of small finger metacarpal requiring osteotomy.

• 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: 10276136
• MDR Text Key: 199531267
• Report Number: 3025141-2020-00159
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• 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