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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.The device was not received for evaluation.Based on the information received, the root cause could not be determined.Related reports: 3025141-2023-00138, 3025141-2023-00139, 3025141-2023-00140, 3025141-2023-00141, 3025141-2023-00142, 3025141-2023-00143, 3025141-2023-00144, 3025141-2023-00145, 3025141-2023-00146, 3025141-2023-00147, 3025141-2023-00148, 3025141-2023-00149, 3025141-2023-00150, 3025141-2023-00151, 3025141-2023-00152, 3025141-2023-00153, 3025141-2023-00154, 3025141-2023-00155, 3025141-2023-00156, 3025141-2023-00157, 3025141-2023-00158, 3025141-2023-00159, 3025141-2023-00160, 3025141-2023-00161, 3025141-2023-00162, 3025141-2023-00163, 3025141-2023-00164, 3025141-2023-00165, 3025141-2023-00166, 3025141-2023-00167, 3025141-2023-00168, 3025141-2023-00169, 3025141-2023-00170, 3025141-2023-00171, 3025141-2023-00172, 3025141-2023-00173, 3025141-2023-00174, 3025141-2023-00175, 3025141-2023-00176, 3025141-2023-00177, 3025141-2023-00178, 3025141-2023-00179, 3025141-2023-00180, 3025141-2023-00181, 3025141-2023-00182, 3025141-2023-00183, 3025141-2023-00184, 3025141-2023-00185, 3025141-2023-00186, 3025141-2023-00187, 3025141-2023-00188, 3025141-2023-00189, 3025141-2023-00190, 3025141-2023-00191, 3025141-2023-00192, 3025141-2023-00193, 3025141-2023-00194, 3025141-2023-00195, 3025141-2023-00196, 3025141-2023-00197, 3025141-2023-00198, 3025141-2023-00199, 3025141-2023-00200, 3025141-2023-00201, 3025141-2023-00202, 3025141-2023-00203, 3025141-2023-00204, 3025141-2023-00205, 3025141-2023-00206, 3025141-2023-00207, 3025141-2023-00208, 3025141-2023-00209, 3025141-2023-00210, 3025141-2023-00211, 3025141-2023-00212, 3025141-2023-00213, 3025141-2023-00214, 3025141-2023-00215, 3025141-2023-00216, 3025141-2023-00217, 3025141-2023-00218, 3025141-2023-00219, 3025141-2023-00220, 3025141-2023-00221, 3025141-2023-00222, 3025141-2023-00223, 3025141-2023-00224, 3025141-2023-00225, 3025141-2023-00226, 3025141-2023-00227, 3025141-2023-00228, 3025141-2023-00229, 3025141-2023-00230, 3025141-2023-00231, 3025141-2023-00232, 3025141-2023-00233, 3025141-2023-00234, 3025141-2023-00235, 3025141-2023-00236, 3025141-2023-00237, 3025141-2023-00238, 3025141-2023-00239, 3025141-2023-00240, 3025141-2023-00241, 3025141-2023-00242, 3025141-2023-00244, 3025141-2023-00245, 3025141-2023-00246, 3025141-2023-00247, 3025141-2023-00248, 3025141-2023-00249, 3025141-2023-00250, 3025141-2023-00251, 3025141-2023-00252, 3025141-2023-00253, 3025141-2023-00254, 3025141-2023-00255, 3025141-2023-00256, 3025141-2023-00257, 3025141-2023-00258, 3025141-2023-00259, 3025141-2023-00260, 3025141-2023-00261, 3025141-2023-00262, 3025141-2023-00263, 3025141-2023-00264, 3025141-2023-00265, 3025141-2023-00266, 3025141-2023-00267, 3025141-2023-00268, 3025141-2023-00269, 3025141-2023-00270, 3025141-2023-00271, 3025141-2023-00272, 3025141-2023-00273, 3025141-2023-00274, 3025141-2023-00275, 3025141-2023-00276, 3025141-2023-00277, 3025141-2023-00278, 3025141-2023-00279, 3025141-2023-00280, 3025141-2023-00281, 3025141-2023-00282, 3025141-2023-00283, 3025141-2023-00284, 3025141-2023-00285, 3025141-2023-00286, 3025141-2023-00287, 3025141-2023-00288, 3025141-2023-00289, 3025141-2023-00290, 3025141-2023-00291, 3025141-2023-00292, 3025141-2023-00293, 3025141-2023-00294, and 3025141-2023-00295.

Event Description

The authors performed a retrospective single-center review of adult distal radius fracture patients treated with a volar locking plate between 2009 and 2019.In total, 2779 patients were included in the study.The primary outcome was a flexor tendon issue (flexor tendon rupture, tendinitis, or flexor irritation), whereas plate removal was a secondary outcome.Using soong grade 0 as a reference, the authors used univariable and multivariable logistic regression to calculate odds ratios (or) with 95% confidence intervals (ci) for flexor tendon issues and plate removal.It was stated acumed acu-loc 2 and acu-loc 1 was used.Flexor tendon rupture, tendinitis, flexor irritations, fixation failure, and plate removal were reported.Report 106 of 158 for the events of flexor tendon rupture, tendinitis, flexor irritations, fixation failure, and plate removal reported in this article.

• 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: 16858140
• MDR Text Key: 314440141
• Report Number: 3025141-2023-00243
• 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: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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: 04/17/2023
• 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