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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VA-LCP; PLATE, FIXATION, BONE
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SYNTHES GMBH UNK - PLATES: VA-LCP; PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)
Event Date 01/01/2024
Event Type  Injury  
Event Description
It was reported that on an unknown date in 2024 the patient had a hardware removal performed due to acute pain and skin rashes over the shoulder area and near the clavicle noted at 10 weeks postop (potential metal/nickel allergy/sensitivity).The patient received csi injection at the shoulder (coracoid area) at 17 weeks postop.The acute pain and erythema eventually resolved, but painful hardware and shoulder pain was noted at 23 weeks, especially at work and at night, disturbing sleep.The complication is related to the depuy device and the procedure performed.No further information is available.This report is for an unk - plate: va-lcp.This is report 1 of 9 for (b))(4).
 
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.: b3: event occurred on an unknown date in 2024.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown plate: va-lcp/unknown lot.Part and lot numbers are unknown; udi 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.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.
 
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.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.
 
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Brand Name
UNK - PLATES: VA-LCP
Type of Device
PLATE, FIXATION, BONE
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 Key18602256
MDR Text Key334024140
Report Number8030965-2024-01500
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2024
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
Date Manufacturer 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
Treatment
UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING; UNK - SCREWS: VA LOCKING
Patient Outcome(s) Required Intervention;
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