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

Device Problem Migration (4003)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/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: chiang cl, yang sw, tsai my, chen ckh (2010)."acromion osteolysis and fracture after hook plate fixation for acromioclavicular joint dislocation: a case report." journal of shoulder and elbow surgery.Volume 19.Page e13-e15 (taiwan).This study presents a case complicated by progressive osteolysis and acromial fracture after hook plate application.This is a case report on a (b)(6) man had painful disability due to displaced right acromioclavicular joint dislocation (rockwood type v) after a traffic accident.Patient had glomerulonephritis-related renal failure and had been undergoing hemodialysis for years.Patient underwent open reduction-internal fixation using an unknown synthes clavicular hook plate ( 4-hole plate with an 18-mm hook depth).No attempt was made to perform a soft-tissue procedure such as coracoclavicular ligament repair in the acute traumatic stage of this case.On the first month after surgery, patient was instructed to perform pendulum exercises and to limit shoulder motion and heavy activities were prohibited.4 months later, patient was advised to remove the hook plate, but patient hesitated because of his surgical outcome was satisfactory and he already regained full range of motion.Follow-up radiographs 4 months after surgery showed unparallel alignment between the hook and acromion and osteolysis over the articular surface with minimal re-subluxation of the acromioclavicular joint.At 8 months after surgery, the patient had painful disability again after lifting a heavy box.Shoulder radiographs then showed acromial fracture, in addition to osteolysis over the acromial undersurface, distal clavicle, and acromioclavicular joint, and the hook cutting upward through the acromion.Hook plate removal and surgical fixation for the acromion fracture were advised again, but the patient still hesitated.A conservative arm sling fixation was applied.At 9 months postoperatively, progressive displacement of the fractured fragment was noted on follow-up radiographs.Even though obvious cosmetic deformity of the right shoulder remains, the patient still presents with a full range of shoulder motion.This report is for one (1) device- an unknown synthes clavicular hook plate.This is report 1 of 1 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: 8266649
• MDR Text Key: 133711993
• Report Number: 8030965-2019-60155
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/22/2019
• 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
• Patient Age: 54 YR