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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L28MM; PLATE, FIXATION, BONE
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STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L28MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 661428
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561)
Event Date 10/21/2022
Event Type  Injury  
Event Description
As reported: pt broke their right humerus and was compliant to all mobility instructions.Patient went to bed and woke up the following morning and experienced pain in their arm and knew that something was wrong.Went into the hospital, x-rays were taken and it was confirmed that the screw heads were broken within 3-4 weeks post op.The headless screws were left in but the plate and remaining screws were removed.Patient was revised and is having no issues with the plate.
 
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.H3 other text : the headless screws were left in but the plate and remaining screws were removed.
 
Event Description
As reported: pt broke their right humerus and was compliant to all mobility instructions.Patient went to bed and woke up the following morning and experienced pain in their arm and knew that something was wrong.Went into the hospital, x-rays were taken and it was confirmed that the screw heads were broken within 3-4 weeks post op.The headless screws were left in but the plate and remaining screws were removed.Patient was revised and is having no issues with the plate.
 
Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation, an image was shared which confirms the alleged failure.The device was not returned for evaluation but an image was provided which showed 2 screws to be broken which appears to be cortical screws, but no further information could be determined apart from this.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The provided primary surgery report was insufficient to reach to any conclusion along with the absence of medical records.More information such as patient's medical records like x-rays as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
CORTEX SCREW AXSOS 3 Ø3.5MM / L28MM
Type of Device
PLATE, FIXATION, BONE
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key16953264
MDR Text Key315467870
Report Number0008031020-2023-00205
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613252580355
UDI-Public07613252580355
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number661428
Device Catalogue Number661428
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/21/2023
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;
Patient Age31 YR
Patient SexMale
Patient Weight82 KG
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