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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TI-CORTEX SCREW 4,5MM IMPLANT

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STRYKER GMBH UNKNOWN TI-CORTEX SCREW 4,5MM IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Perforation (2001); Hip Fracture (2349); Non-union Bone Fracture (2369)
Event Date 09/02/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device remains in the patient.
 
Event Description
As reported: "in 2017, internal fixation with twin hook was used for femoral neck fracture and t2 nail was used for femoral supracondylar fracture. Four years postoperatively, the appearance of abdominal pain led to pelvic perforation of the hook pin, pseudoarticulation of the femoral neck, and fracture of the distal screw. Revision surgery was performed, the fractured screws were left in the bone and the hook was removed. There was no internal damage. ".
 
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Brand NameUNKNOWN TI-CORTEX SCREW 4,5MM
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12537501
MDR Text Key273530241
Report Number0008031020-2021-00422
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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 Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
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