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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL PROTECT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES?

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SYNTHES GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL PROTECT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES? Back to Search Results
Catalog Number UNK - CONSTRUCTS EXPERT TIBIAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
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. Report is for an unknown device/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. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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.
 
Event Description
This report is being filed after the review of the following journal article: el zohairy mm, et al. (2021), treatment of extra articular distal third tibia fracture: plating versus nailing, european journal of molecular & clinical medicine, volume 08, issue 03, page 2774-2783 (egypt). The purpose of this study is to evaluate and compare the operative data and postoperative outcomes between plate fixation, and intramedullary nail technique for identifying proper indications of both methods of fixation. Between january 2015 to december 2019, 96 patients (mean age of 39 years, range 18-60) with distal tibial fractures who had been treated using either minimal invasive plate osteosynthesis technique or expert intramedullary nail technique were included in the study. 48 patients were treated with minimal invasive plate osteosynthesis technique using unknown plates while the other 48 patients were treated with an unknown synthes expert tibial nail. Non-weight bearing mobilization was started which progressed to partial weightbearing after 4 weeks at least and full weightbearing was advised once considerable callus was formed. Active range of movements of knee and ankle were initiated as soon as the patient¿s skin condition and pain permitted. Complications were reported as follows: 4 patients had constant pain and stiffness. 20 patients had pain while walking on uneven surface. 8 patients had constant swelling. 24 patients had swelling in the evening. This report is for the unknown synthes expert tibial nail.
 
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Brand NameUNK - CONSTRUCTS: EXPERT TIBIAL NAIL PROTECT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES?
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14250366
MDR Text Key290457886
Report Number8030965-2022-02821
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS EXPERT TIBIAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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