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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE

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STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 2030-6525-1
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 07/15/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right hip was revised due to instability and dislocation of the head from the poly liner.The shell was revised due to the surgeon needing more anteversion.Patient was revised to a 28mm + 12 mm l fit v40 femoral head, a 28/52 mm restoration adm/mdm x3 insert, a 46 mm mdm cementless liner, and 56 mm trident ii clusterhole ha shell with three 6.5mm x 15 mm screws and onw 6.5 mm x 20 mm screw.Rep confirmed that no further information would be released by the hospital or surgeon.
 
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Brand Name
6.5 CANCELLOUS BONE SCREW 25MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10364860
MDR Text Key201739012
Report Number0002249697-2020-01603
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07613327036992
UDI-Public07613327036992
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial
Report Date 08/04/2020
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 Health Professional
Device Expiration Date07/31/2024
Device Model Number2030-6525-1
Device Catalogue Number2030-6525-1
Device Lot Number415767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2019
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) Hospitalization; Required Intervention;
Patient Age63 YR
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