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

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Injury (2348); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown philos plates and screws constructs/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.

Event Description

This report is being filed after the review of the following journal article: chen c., et al (2020) preliminary clinical and radiographic outcomes of proximal humeral fractures: comparison of alps and philos plating in asian patients in taiwan, journal of orthopaedic surgery and research volume 15, pages 1-7 (taiwan).This non-randomized retrospective study aims to report the preliminary clinical and radiographic outcomes of alps treatment for proximal humeral fractures compared to philos treatment in an asian population in taiwan.Between january 2016 and december 2018,a total of 66 patients (19 males, 47 females) with a mean age of 58.9 years (range, 19¿84 years) with proximal humeral fractures received an open reduction and internal fixation (orif) using locking plates.Thirtyfive patients were treated with philos (synthes, solothurn switzerland) (philos group), and 31 patients were treated with alps proximal humerus plating system (zimmer biomet, warsaw, indiana, usa),(alps group).The mean follow-up period was 400.8 days (range, 367¿ 446 days).The following complications were reported as follows: of the 66 patients, 65 patients (men, 18; women, 47) had complete bone union.Postoperative radiography on x-ray view revealed varus malunion in six patients (6/35).Shoulder stiffness was noted in two patients in both groups.6 avn.4 subacromial impingement.Patients treated with philos, the reoperations were related to a postoperative infection (n = 1).Patients treated with philos, the reoperations were related to a screw protrusion (n = 1).3 screws/pegs protrusion.This report is for an unknown synthes philos plates and screws construct.This report captures the adverse events of malunion, avn, subacromial impingement and postoperative infection.This is report 1 of 5 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10759401
• MDR Text Key: 217077245
• Report Number: 8030965-2020-08390
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 10/05/2020
• 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