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

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

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); No Code Available (3191)

Event Date 07/08/2009

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: krukhaug, y.And hove, l.(2009), experience with the ao plate for displaced intraarticular fractures of the distal radius, scandinavian journal of plastic and reconstructive surgery and hand surgery, vol.38(5), pages 293-296 (norway).The aim of this article is to use open reduction and internal fixation (orif) with the ao plate in 32 displaced, intraarticular fractures of the distal radius.Between 1998 and 2001, a total of 32 patients (26 males and 6 females) with a median age at the time of injury was 48 (22-74) years were treated with an open reduction internal fixation (orif) using an unknown synthes ao plate, screws and pins.Only 29 patients were followed up after a median of 23 (9-46) months.The plate has been removed in 9 patients.The following complications were reported as follows: 3 patients had some cold intolerance.2 patients had reduced strength in the thumb extensors.1 patient had an amputation neuroma of the superficial branch of the radial nerve.1 patient had adhesions of the flexor tendons of the 2nd and 3rd fingers because the screws were too long and had penetrated the tendon sheaths.This is for an unknown plates.This report captures cold intolerance, reduced strength, amputation neuroma of the superficial branch of the radial nerve, adhesions of the flexor tendons of the 2nd and 3rd fingers because the screws were too long and had penetrated the tendon sheaths.This is report 1 of 3 for complaint (b)(4).

• Brand Name: UNK - PLATES
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8809053
• MDR Text Key: 151642778
• Report Number: 8030965-2019-66444
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/19/2019
• 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