MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; APPLIANCE, FIXATION, NAIL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

A total of 58 patients (27 males and 31 females) with a mean age of 70 years (range, 16-94 years) were included in the study.This report is for an unknown dcs 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.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: sushrut s.Kulkarni and christopher g.Moran (2003), results of dynamic condylar screw for subtrochanteric fractures, injury-international journal of the care of the injured vol.34(n), pages 117-122 (united kingdom).The aim of this article is to review the results of treating subtrochanteric fractures using the dcs and identify important factors that influence the outcome.Between 1990-1997, a total of 58 patients (27 males and 31 females) with a mean age of 70 years (range, 16-94 years) were included in the study.These patients were treated with dynamic condylar screw (dcs) for subtrochanteric fractures.The mean duration of follow-up was 8 months.The following complications were reported as follows: intraoperative problem was noted such as an ill-fitting plate.Additional complications are captured on related complaint (b)(4).This report is for an unknown dcs plate.This is report 9 of 9 for (b)(4).

• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 8675392
• MDR Text Key: 147238937
• Report Number: 8030965-2019-64995
• Device Sequence Number: 1
• Product Code: KTT
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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
• Date Manufacturer Received: 05/10/2019
• 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