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

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00281: plate; 3025141-2017-00282: screw 1; 3025141-2017-00284: screw 3; 3025141-2017-00285: screw 4; 3025141-2017-00286: screw 5; 3025141-2017-00287: screw 6; 3025141-2017-00288: screw 7; 3025141-2017-00289: screw 8.

Event Description

An implanted clavicle plate bent postoperatively and was explanted.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7022543
• MDR Text Key: 91807336
• Report Number: 3025141-2017-00283
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• 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
• Patient Age: 32 YR