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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS SCREW MULTI-A 6.75 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US RADIUS SCREW MULTI-A 6.75 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 486611640
Device Problems Device Slipped (1584); Migration (4003)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative
Stryker was made aware of a related device complaint on (b)(6) 2019 (mrn 3004024955-2019-00004).On (b)(6) 2019, additional information was provided to stryker indicating a complaint related to a concomitantly implanted screw.Three catalog numbers were provided for the screw, 48611640, 486611645, and 486611650; it is unknown which catalog number pertains to this device.Catalog number 48611640 has been populated in this report.This device information will be updated in a supplemental report upon receipt of additional clarifying information from the reporting physician.
 
Event Description
The device was implanted (b)(6) 2016.The patient began to experience discomfort attributed to the concomitantly implanted cage in (b)(6) 2017.Revision surgery was performed to address the concomitant device on (b)(6) 2019.During revision, the physician noted that this device (l4 screw) was, "slightly loose," then removed and replaced it.
 
Event Description
The device was implanted (b)(6) 2016.The patient began to experience discomfort attributed to the concomitantly implanted cage in (b)(6) 2017.Revision surgery was performed to address the concomitant device on (b)(6) 2019.During revision, the physician noted that this device (l4 screw) was, "slightly loose," then removed and replaced it.
 
Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.A review of complaint and device history records could not be performed as a valid lot code was not provided and could not be obtained.The updated information from the operation notes and review of primary surgery records states that one screw was "slightly loose." this cannot be confirmed based on images received.Not returned by hospital.
 
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Brand Name
RADIUS SCREW MULTI-A 6.75 X 40MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8563273
MDR Text Key143711384
Report Number0009617544-2019-00062
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540544483
UDI-Public04546540544483
Combination Product (y/n)N
PMA/PMN Number
K062270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number486611640
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age37 YR
Patient Weight82
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