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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plate.Pma/510(k) number is not available.Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: lin, h.Et al, clavicular hook plate may induce subacromial shoulder impingement and rotator cuff lesion - dynamic sonographic evaluation, journal of orthopaedic surgery and research 2014, 9:6, pages 1-9, (taiwan).The aim of the study was to seek to determine whether the clavicular hook plate fixation may induce subacromial shoulder impingement by dynamic musculoskeletal sonography as an evaluation tool.Moreover, it was the objective to know the association between the hardware-induced problems and clinical outcome of patients in terms of shoulder functional score.The study followed 42 patients with either distal clavicle fractures or acromioclavicular joint dislocations that had surgery using the synthes arbeitsgemeinschaft für osteosynthesefragen (ao) clavicular hook plate from december 2007 to january 2010.The hook plate was a modified stainless steel, curved 3.5 mm dynamic compression plate.The mean age of the patients at surgery was 37.68 years.There were 32 men and 10 women.All patients were evaluated by monthly clinical and radiographic examinations.Static and dynamic musculoskeletal sonography examinations were performed at final follow-up before implant removal.Clinical results for pain, shoulder function, and range of motion were evaluated using constant-murley and disability of arm, shoulder, and hand (dash) scores.One female elderly patient , (b)(6), died of unrelated causes during follow-up.One patient had delayed fracture union.The delayed union resulted from the implant fixation failure.Radiological assessment revealed cutout of the two screws from the clavicle and that the hook of the plate had partially disengaged from the acromion.The patient¿s shoulder was immobilized in a sling for 1 month.The implant was removed 4 months following injury.20 patients demonstrated variable degrees of acromial erosion.From serial radiographic analyses, it was noticed bony osteolysis appeared 2 months postoperatively and were still visible 4 weeks after plate removal.6 patients had rotator cuff lesions at the bursal aspect on the operated shoulder.Under musculoskeletal sonography, mechanical cuff attrition was observed as a flattened, concave discontinuity of tendon fiber with decreased echogenicity and this finding was less remarkable after implants removal.These focal changes of the rotator cuff involved the posterior third of supraspinatus tendon.6 patients with rotator cuff pathology also developed subacromial shoulder impingement.In total, 15 patients developed subacromial shoulder impingement.All of the subacromial impingements occurred unilaterally and specifically on the injured shoulder.The mean constant-murley score was 83 (range 64¿ 100) for all 40 patients.The mean dash score was 14.43 (range 0¿57).3 patients demonstrated evidence of subacromial bursitis (grade 2).Abnormal upward migration and difficult passage of the humeral head underneath the acromion (grade 3) were noted in four patients.A (b)(6) man received hook plate fixation for left ac dislocation and in the anteroposterior view of the left shoulder 3 months postoperatively before implant removal, showed remarkable acromial osteolysis.The bony defect was still visible 1 month after implant removal.A (b)(6) man who had shoulder impingement syndrome before implant removal revealed a partial thickness tear was noted at the bursal aspect of the supraspinatus tendon (ssp), which resulted from repetitive mechanical attrition by the hook of the plate, as shown in the sonographic findings.The infraspinatus tendon (isp) was intact.1 month after implant removal, the same patient was re-evaluated.Musculoskeletal sonography showed the dimpling lesion had become less obvious than before.A (b)(6) man developed shoulder impingement syndrome after receiving hook plate fixation of a left distal clavicle fracture was shown in the dynamic musculoskeletal sonography findings.The treated shoulder was passively and forwardly elevated from a neutral position towards 180° elevation.It was stopped at 120° when the patient reported intolerable pain.At 90° forward elevations, bunching of supraspinatus tendon fibers was noted accompanied with distention of the subacromial/subdeltoid bursa (arrow) signifying flowing fluid of bursitis.Another remarkable finding is abnormal superior translation of humeral head with regard to the acromion obstructing its passage beneath the acromion.A (b)(6) man who received hook plate fixation of a right distal clavicle fracture developed shoulder impingement syndrome.Musculoskeletal sonography revealed subacromial/subdeltoid (sasd) bursitis with flowing fluid before implant removal.Four weeks after implant removal, the same patient was reevaluated.Sonographic finding showed unobstructed passage of the humeral head into the acromion and disappearance of the flowing fluid.Ssp, supraspinatus tendon.This report is for unknown ao clavicle hook plates.This is report 3 of 6 for (b)(4).A copy of the literature article is being submitted with this medwatch.
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Type of Device
Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key8271647
MDR Text Key133892551
Report Number8030965-2019-60204
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
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 Received01/23/2019
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 Received01/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR