MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screw/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.Implant date is between april 2006 to march 2007.(b)(4).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: kato, s.Et al (2014), the results of volar locking plate fixation for the fragility fracture population with distal radius fracture in japanese women, nagoya journal of medical science, vol.76 (1-2), pages 101-111 (japan).The aim of this matched case-control, multi-center clinical prospective cohort, prospective, clinical follow-up study is to evaluate whether anatomical repair of the drf with the volar locking plate benefits japanese fragility fracture population patients (women aged 55 years and older) in terms of complications, as well as function and disability.Between april 2006 to march 2007, a total of 100 patients (50 male and 50 female) were included in the study.All male patients (group a) with a mean age of 44.6 (range 20¿73) years were matched with all female patients (group b) with a mean age of 68.8 (range 55¿84) years.Surgery was performed using 3 different volar locking plates, where one of these is the locking drp system (synthes, paoli, pa, usa) used in 25 patients in group a and 23 patients in group b.The mean follow-up period was unknown.The following complications were reported as follows: group a: 1 patient had median nerve palsy.1 patient had carpal tunnel syndrome (cts).2 patients had numbness of unknown lesion.1 patient had an extensor tendon rupture.1 patient had a wound infection.1 patient had a loss of reduction.1 patient had a peri-plate pain.1 patient had a wrist swelling.Group b: 6 patients had carpal tunnel syndrome (cts).1 patient had numbness of radial nerve.2 patients had numbness of unknown lesion.1 patient had crps.1 patient had a trigger finger.1 patient had a flexor tendon partial rupture.1 patient had an extensor tendon rupture.1 patient had an ulnar pin site infection.1 patient had a loss of reduction.2 patients had wrist swelling.1 patient had a screw cut out.This report is for an unknown synthes lcp volar distal radius plates and unknown synthes screws.This report is for one (1) unknown screw.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,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: 10407490
• MDR Text Key: 209793351
• Report Number: 8030965-2020-05967
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 07/22/2020
• 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