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

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

Patient Problems Calcium Deposits/Calcification (1758); Edema (1820); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)

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.(b)(4).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: natera cisneros, lg.And reiriz, js.(2017), acute high-grade acromioclavicular joint injuries: quality of life comparison between patients managed operatively with a hook plate versus patients managed non-operatively, european journal of orthopaedic surgery & traumatology, vol.27(3), pages 341¿350 (spain).The aim of this retrospective cohort study is compare the qol of patients with acute high-grade acromioclavicular joint (acj) injuries managed operatively with hook plate versus the quality of life (qol) of patients managed non-operatively, 24 months or more after shoulder injury.Between january 1, 2008 and january 31, 2012, a total of 32 patients (29 male and 3 female) were included in the study.Patients were treated surgically by means of an open reduction and internal fixation with unknown synthes hook plates (plate group) consisted of 11 patients (11 male and 0 female) with a mean age of 41 years (range, 19-55 years) or conservatively (cons group) consisted of 21 patients (18 male and 3 female) with a mean age of 38 years (range, 19-55 years).Radiographic follow-up evaluations were based on the x-rays performed at the last follow-up.The minimum follow-up was 24 months after treatment decision.The following complications were reported as follow: 2 patients had incidence of scapular dyskinesis at the last follow-up visit.4 patients had incidence of acromioclavicular joint (acj) dislocations at the last follow-up visit.2 cases of subluxations were observed.2 cases of complete dislocations were observed.3 cases of calcification of the cc ligaments of the shoulders were observed.3 cases of the lateral end of the clavicle showed osteolysis.1 patient developed a severe pain several months after plate was removed.Mri was performed, 1 unknown case of an important subacromial edema was revealed and this was managed by means of a corticoid injection, and the symptoms subsided.1 patient had surgical site infection that required a surgical debridement, and the breakage of a screw that could not be removed from the clavicle.This report is for an unknown hook plate.This is report 1 of 3 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: 8272136
• MDR Text Key: 133911899
• Report Number: 8030965-2019-60226
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/04/2019

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: 01/04/2019
• 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