MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; CONDYLAR PLATE FIXATION IMPLANT

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary 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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: wang c et al (2015).Complete acromioclavicular joint dislocation treated with reconstructed ligament by trapezius muscle fascia and observation of fascial metaplasia.Open medicine.Volume 10.Pages 370-376.(china) the aim of this study was to estimate the long-term clinical results of this method in 12 patients with acute tossy grade iii ac joint dislocation and to observe any fascial metaplasia.Between august 2008 and may 2012, 12 patients with acute complete acromioclavicular joint dislocations (8 males, 4 females; mean age 36.08 years; range, 19 to 59 years) who were treated with reconstructed ligament by trapezius muscle fascia were included in the study.All patients were implanted with an unknown ao clavicular hook plate.Clinical and radiographic follow-up was done every 4 to 6 weeks for 12 months postoperatively.All patients received clinical follow-up, as assessed by clinical results and radiographic follow-ups.Functional results were evaluated at the last follow-up visit by using the constant scoring system.The constant score combines subjective symptom scores (percent), which assess pain and vocational activities, and objective scores percent), which measure the range of motion and shoulder strength.The score values range from 0 to 100, with higher scores indicating better shoulder function.Follow-up times ranged from 16 to 38 months (mean, 22.83 ± 6.26 months).Complications were reported as follows: 5 patients had mild pain during activities postoperatively.The symptoms of shoulder pain and soreness were exacerbated by wet and cold weather.3 of these patients had constant scores from 80 to 90 which are the following: a (b)(6) male had mild pain during activity, but this did not affect the range of motion of the shoulder.Patient¿s constant score is 86.A (b)(6) male had mild pain during activity, but this did not affect the range of motion of the shoulder.Patient's constant score is 83.A (b)(6) female had mild pain during activity, but this did not affect the range of motion of the shoulder.Patient's constant score is 81.This report is for one (1) device- an unknown ao clavicular hook plate.This report is for a (b)(6) male had mild pain during activity, but this did not affect the range of motion of the shoulder.Patient¿s constant score is 86.This is report 2 of 4 for (b)(4).A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8274543
• MDR Text Key: 134014228
• Report Number: 8030965-2019-60253
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR