MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE,FIXATION,BONE

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

Patient Problems Loss of Range of Motion (2032); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plates/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kim,y.Et al, "in vivo analysis of acromioclavicular joint motion after hook plate fixation using three-dimensional computed tomography," journal of shoulder and elbow surgery, volume 24, issue 7, july 2015, pages 1106-1111 (south korea).The aim of the study was to describe the change in 3-dimensional (3d) motion of the distal clavicle compared with the normal (without hook plate fixation) shoulder.Seven patients (5 men and 2 women) with comminuted distal clavicular fractures (neer type ii-b) were enrolled prospectively.The mean age was 42 years (range, 24-60 years).The synthes hook plate was used in the patients.3d-ct scans were taken at 3.2 months (range, 3-4 months) after the primary surgery.Zero degree images and abduction images were obtained.The sagittal cut surface was obtained 5 mm medial from the distal clavicle.The equator of the cut surface of the clavicle was compared with the full abduction model to analyze rotation.The center of the cut surface of the clavicle was compared with the full abduction model to analyze translation.A (b)(6) man (patient 1) showed decreased internal rotation of the distal clavicle with respect to the medial acromion at the neutral and full abduction positions in the reconstructed 3-dimensional model.The internal rotation was decreased in the operated-on shoulder compared with the normal shoulder.Reconstructed 3-dimensional model of the same (b)(6) man (patient 1) showed anterior translation of the distal clavicle with respect to the medial acromion at the neutral and full abduction positions.The anterior translation was increased in the operated-on shoulder compared with the normal shoulder.Patients 5, 6, and 7 showed decreased abduction compared with the opposite shoulder.Acromial erosion was found in all patients.This report is for an unknown synthes hook plates.This is report 2 of 2 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8271903
• MDR Text Key: 133910667
• Report Number: 8030965-2019-60220
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention