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

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.This report is for unknown quantity of unknown plates.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown quantity of unknown plates.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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: zhang bing, et al (2012).Application of ao miniplate and screw in the treatment of metacarpophalangeal joint periarticular fractures.National medical journal of china.Volume 92.Number 3.Pages 188-191.(china).The purpose of this study is to evaluate the clinical efficacies for open reduction and internal fixation of unstable periarticular fractures of the metacarpophalangeal joint with the ao miniature plate system.Between april 2006 to august 2010, 265 patients with 302 cases of metacarpophalangeal joint periarticular fractures who underwent open reduction and internal fixation, were included in the study.There were 172 males and 93 males with a mean age of 32.5 years old (range, 17-59 years).Fixation was done using an unknown ao miniplate system.Patients were followed up for an average of 4.6 months (range, 4-24 months).Post-operative x-ray films were reviewed regularly and physical labor was normally performed after fracture healing.Complications were reported as follows: 15 cases of joint stiffness; 15 case of fracture malunion; 17 cases of traumatic arthritis; 20 cases of tendon adhesion; 1 case of incision infection.This report is for unknown quantity of unknown plates.This is report 1 of 1 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7772869
• MDR Text Key: 116795101
• Report Number: 8030965-2018-55626
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/24/2018

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: 07/24/2018
• Initial Date FDA Received: 08/10/2018
• 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