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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2019-00698: case 1, 3025141-2019-00699: case 2.

Event Description

Article: precontoured plating of clavicle fractures - decreased hardware-related complications?; vanbeek, corinne, md; boselli, karen j., md; cadet, edwin r., md; ahmad, christopher s., md; levine, william n., md; clin orthop relat res (2011) 469:3337-3343.Case 3: patient's broken clavicle was treated by implanting an acumed locking clavicle plate.Patient experienced nonunion which was revised with a plate and bone grafting.

• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9527112
• MDR Text Key: 182225939
• Report Number: 3025141-2019-00700
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• 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