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

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

Patient Problems Erosion (1750); Bone Fracture(s) (1870); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the journal article.510k: this report is for an unknown hook plate /unknown lot.Part and lot number are unknown; udi number is unknown.Dates of implant are unknown dates between december 2004 and august 2010.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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.

Event Description

This report is being filed after the review of the following journal article: chen et al (2014), comparison of single coracoclavicular suture fixation and hook plate for the treatment of acute unstable distal clavicle fracture, journal of orthopaedic surgery and research, pages 1-6 (taiwan).The objective of this study is to retrospectively evaluate the clinical results and efficacy comparison of single coracoclavicular (cc) suture fixation with mersilene tape versus clavicular hook plating.Between december 2004 and august 2010, a total of 68 patients were included in the analysis.These patients were divided into two groups; mersilene tape group (m group) consisted of 40 patients (28 male and 12 female) with a mean age of 43.2 years (range, 18-75 years) while the clavicle hook plate (h group) consisted of 28 patients (16 male and 12 female) with a mean age of 48.3 (range, 28-78 years) who had neer type iib distal clavicle fractures utilized (synthes-stratec medical solothurn, switzerland) clavicle hook plates as fracture treatment.Clinical recovery was evaluated at least 24 months postoperatively, including: the patient-completed oxford shoulder score [20] which was stratified into satisfactory function (40-48 points), mild to moderate dysfunction (30-39 points), moderate to severe dysfunction (20-29 points), or severe dysfunction (0-19 points); and the clinician-completed university of california at los angeles (ucla) shoulder rating scale [21], which was stratified by good to excellent result (27-35 points) or fair to poor result (<27 points).The visual analogue scale (vas) for pain and satisfaction score (0-10) were also analyzed in detail.The mean follow-up period for m group was 38.2 months (range, 24-64 months) while the h group was 37.4 range (range, 24-68 months).The following complications were reported as follows: 2 patients had acromial osteolysis, and the symptom subsided after removal of hook plate.1 patient had acromial fracture which resulted from erosion of the acromion by the hook plate; the patient received removal of the implant and protection by an arm-sling for 4 weeks, and no residual symptom was noted finally.Visual analogue scale score - 0.5 (0-2).Satisfaction score ¿ 95 (8-10).This report is for an unknown synthes 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 wright lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8102940
• MDR Text Key: 128312494
• Report Number: 8030965-2018-58459
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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: 11/09/2018
• 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