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

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

Patient Problems Cyst(s) (1800); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for unknown plates.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plates.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: zhang jh et al (2010), comparison of humeral head replacement and internal fixation for the treatment of 3 parts and 4 parts fractures of proximal humerus in the elderly, china j orthop & trauma, volume 23, number 6, pages 435-442.(china).This study aims to compare the indication, technical keys during surgery and early results of humeral head replacement and internal fixation for the 3 parts and 4 parts fractures of the humerus in the elderly.From july 2004 to july 2006, 58 patients with 3 parts and 4 parts fractures of the proximal humerus who were treated with either an unknown ao locking compression plate or a humeral head replacement were included in the study.The lcp group consisted of 28 patients with 12 males and 16 females with an average age of 66.5+/-1.4 years.Postoperative complications, mobility of shoulder joint, and healing time of fracture of greater tubercle were observed immediately after the operation, and at 2, 6, 10 and 16 weeks and 6 months after the operation, as well as at the final follow-up visit.At the final follow-up visit, vas pain score (0-5 scores, 0=painless, 5=most painful) simple shoulder test questionnaire, american shoulder and elbow surgeon score, constant-murley score and ucla score at evaluation and latest follow-up.The mean follow-up period for the lcp group was 29.8 months.Complications were reported as follows: 2 patients with dislocation were found to have varying degrees of cystic deformation of the humeral head and joint space change at follow-up visits.1 of the patient is a (b)(6) year-old male had fracture nonunion and cyst formation in humeral head that happened at 12 months after surgery.Small humeral head necrosis, signs of traumatic arthritis, and obvious pain during movement were closely observed.This report is for unknown plates.It captures cystic deformation of the humeral head; joint space change.This is report 1 of 4 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 ; 6107195000
• MDR Report Key: 8637984
• MDR Text Key: 146065581
• Report Number: 8030965-2019-64468
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• 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: 04/25/2019
• 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