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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNK SONICANCHOR; IMPLANT

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STRYKER TRAUMA KIEL UNK SONICANCHOR; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available to stryker.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the fixation of sutures and soft tissue with the sonicanchor¿ which was released in june 2018 and is associated with the stryker sonic anchor system, within that report, postoperative complications/ adverse events were reported, which occurred between february 2016 and april 2018.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the report, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses pulmonary embolism.
 
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Brand Name
UNK SONICANCHOR
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
melissa guattery
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7723569
MDR Text Key115189816
Report Number0009610622-2018-00401
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 health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/26/2018
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? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/03/2018
Initial Date FDA Received07/26/2018
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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