• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5/4.0 MM LCP PLATE/SCREWS; PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH UNK - CONSTRUCTS: 3.5/4.0 MM LCP PLATE/SCREWS; PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 06/12/2023
Event Type  Injury  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D1, d2, d3, d4, g4-510k: this report is for an unknown 3.5mm lcp plate/screws construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: van rooijen, j.L.Et al (2023), a ¿logsplitter¿ like injury of the ankle: a case report, foot & ankle surgery: techniques,reports & cases 3 (100305), pages 1-5 (netherlands).The main goal in the treatment of talar body fractures is to restore the joint congruity of the tibio talar and subtalar joints.During the study period, a 70-yeary-old female patient with a painful left ankle (were swollen and patient was unable to bear weight) after falling down the stairs was included in the study.Patient presented a displaced sagittal talar body fracture,and a lauge-hansen pronation-abduction-ankle fracture with a displaced anterolateral intraarticular tibia fracture, a distal fibula fracture, combined with a syndesmotic injury.An external fixator was applied as initial treatment.Second operation was performed 14 days after the injury when swelling subsided (an anterolateral approach was used).The talar fracture was reduced and stabilized with 4.5mm headless compression screws (depuy synthes), the tillaux fragment was reduced and stabilized with 4.0mm cannulated screws (depuy synthes), the comminuted fracture was reduced and stabilized with a 3.5 mm lcp bridging plate (depuy synthes), and the syndesmotic injury was treated with a positioning screw (depuy synthes) through the plate.The following complications were reported as follows: - some of the hardware was removed due to irritation 12 months after the initial surgery.This report is for one (1) unk - constructs: 3.5mm lcp plate/screws.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK - CONSTRUCTS: 3.5/4.0 MM LCP PLATE/SCREWS
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key18801124
MDR Text Key336509450
Report Number8030965-2024-03000
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,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
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 02/20/2024
Initial Date FDA Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexFemale
-
-