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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Necrosis (1971); Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown philos plates and screws/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: wang, j. Q. Et al. (2020), comparison between minimally invasive deltoid-split and extended deltoid-split approach for proximal humeral fractures: a case-control study, bmc musculoskeletal disorders, vol. 21(406), pages 1-6 (china) https://doi. Org/10. 1186/s12891-020-03417-9. The aim of this study is to perform a retrospective analysis comparing clinical outcomes between surgical intervention types in proximal humeral fractures (phf). From january 2016 to december 2018, 115 patients underwent philos plate fixation (synthes, oberdorf, switzerland). 64 patients (27 males and 37 females)were treated using the minimally invasive deltoid-split approach (mippo group), and 51 patients (25 males and 26 females) were treated using the extended deltoid-split approach (orif group). The following complications were reported as follows: 3 patients had wound infections. All infection controlled by local dressing change and antibiotic injection. 5 patients had delayed union. All fractures healed eventually. 3 patients had subacromial impingement syndrome. The symptoms improved after internal fixation was removed. 1 patient had head necrosis. It was treated via shoulder hemiarthroplasty 1 patient had a screw cutting out. It after internal fixation was removed. This report is for an unknown synthes philos plates and screws. It captures the reported wound infections, delayed union, subacromial impingement syndrome and head necrosis. This is report 1 of 2 for (b)(4).

 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, 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 Key10786259
MDR Text Key214608962
Report Number8030965-2020-08557
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
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 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/04/2020 Patient Sequence Number: 1
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