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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN SONICANCHOR CASE 9; IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN SONICANCHOR CASE 9; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Implant Pain (4561); Swelling/ Edema (4577)
Event Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
 
Event Description
The manufacturer became aware of a literature published by orthoarizona, usa.The title of this report is ¿stryker sonicanchorstm: case series of distal fibula stress reactions¿ which is associated with the stryker ¿sonicanchors¿ system.This report includes research done on 135 patients between 2017 and 2020.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses 9 cases of swelling and pain around the anchor site which required implant removal and debridement.The report states: ¿patients returned to clinic for clinical reevaluation of swelling and pain around the anchor site itself.Patients were initially treated with a walking boot for immobilization, anti-inflammatories and activity modification for 2-4 weeks.If this did not improve their symptoms, mri was ordered.Mri confirmed bone marrow edema around the sonicanchortm.9 patients (6.67%) returned to the operating room for excision of implant(s) with debridement.¿.
 
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Brand Name
UNKNOWN SONICANCHOR CASE 9
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12519417
MDR Text Key272929526
Report Number0009610622-2021-00720
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial
Report Date 09/23/2021
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 Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2021
Initial Date FDA Received09/23/2021
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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