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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Ossification (1428); Non-union Bone Fracture (2369); Impaired Healing (2378); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - constructs: tomofix plate/screws/unknown lot. Part and lot numbers 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. 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: ung l, et al. (2020), clinical and radiological outcomes after surgical treatment of lower limb fractures in patients with spinal cord injury, global spine journal, volume 10, number 6, pages 715-719, (germany). The main objective of the present study is to analyze the clinical outcome of lower limb fractures with special focus on complications and the prevalence of malunions or nonunions in patients following spinal cord injury. Between january 2003 and december 2015, 58 spinal cord injured patients who have received an external or internal bone fixation following a lower limb fracture were enrolled in the study. There were 44 males and 14 females with a mean age of 60 years (range 31-84 years). The patients were divided into 2 groups: internal fixation (group 1) and external fixation (group 2). 17 patients received an external fixation and 41 an internal fixation. For internal osteosynthesis plates were mainly used which includes the unknown synthes tomofix plates, unknown synthes less invasive stabilization system (liss) plate and competitors¿ fixation devices. The date of bone consolidation was evaluated until plain radiographs that were taken during the routine outpatient clinic follow-up examinations. The article did not specify which patients were implanted with the synthes devices. Thus, complications will be reported as follows: 27 patients had pseudarthrosis. Unknown patients (10 percent) had wound infection. Unknown patients (8 percent) had heterotropic ossification. Unknown patients (2 percent) had wound healing disorders. This report is for the unknown synthes tomofix locking plate system and unknown synthes less invasive stabilization system (liss) plate. This report is for one (1) unk - constructs: tomofix plate/screws. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12547972
MDR Text Key275415505
Report Number8030965-2021-08127
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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