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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PL COLLAR 7 H/81 PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PL COLLAR 7 H/81 PLATE, FIXATION, BONE Back to Search Results
Model Number 241.371
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
It was reported on an unknown date that the patient reported blisters on surgical foot, which has spread to other parts of her body. Patient is being tested for an allergic reaction to the implants. No further information. This report is for one (1)lcp one-third tubular pl collar 7 h/81. This is report 4 of 6 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). 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. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: patient. 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.
 
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Brand NameLCP ONE-THIRD TUBULAR PL COLLAR 7 H/81
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15183710
MDR Text Key297436979
Report Number2939274-2022-03162
Device Sequence Number1
Product Code HRS
UDI-Device Identifier10886982166890
UDI-Public(01)10886982166890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011335
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number241.371
Device Catalogue Number241.371
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/08/2022 Patient Sequence Number: 1
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