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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - CONSTRUCTS: LCP ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown constructs: lcp/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. (b)(4). 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
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: kempný t. Et al. (2019), use of medial femoral condyle flap and anterolateral thigh free flap in proximal tibial posttraumatic non-union with multiple anastomosis ¿case report, acta chirurgiae plasticae, vol. 61, pages 1-4 (austria). This study presents a case report of a (b)(6) year-old male patient suffered an intraarticular fracture of proximal tibia and fibula in a motorbike accident, classified as 4c3 ao. An angiography with contrast proved an obstruction of the distal part of popliteal artery caused by fracture bone fragments external compression. An opened fixation with locking compression plate (lcp) on proximal tibia (depuy, synthes) was performed after seven days following the admission. Shortly after the surgery, primary symptoms of compartment syndrome appeared in the region of the distal lower limb which was treated with septal fasciotomy. An x-ray examination performed six months after the initial reconstructive surgery has shown signs of non-union located in the previous fracture line along with a fistula opening on the skin surface. Th e culture from fistula was positive for staphylococcus aureus. The lcp in proximal tibia was removed and a radical debridement six weeks after the final reconstructive procedure, the patient was capable of full range of motion in the knee. This report is for an unknown synthes lcp. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: LCP
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key12232967
MDR Text Key266621402
Report Number8030965-2021-06115
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
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 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
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 Received07/12/2021
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: 07/27/2021 Patient Sequence Number: 1
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