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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE
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STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 656418
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event Description
As reported: "screw head broke off.".
 
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Brand Name
BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE   D-79111
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10393855
MDR Text Key203497064
Report Number0008031020-2020-02159
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07613327068955
UDI-Public07613327068955
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180500
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 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number656418
Device Catalogue Number656418
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/16/2020
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
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