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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problems Fracture (1260); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
Request has been made for patient, device, and event details but the information has not yet been provided.Return status of the device/devices is currently unknown.
 
Event Description
A company representative reported that an unspecified number of events in which the serrato screw fractured the pedicle during insertion.No information is currently available regarding the number of occurrences, the length of any resulting surgical delays, and how or if each surgery was completed.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.For larger diameter screws, there is more torque applied at the upper part of the screw due to the cancellous cortical thread design combined with a dual lead.Undertapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.It is unknown if the surgeon tapped or if undertapping occurred.A definite root cause cannot be determined based on the information provided.Possible root causes include lack of tapping, undertapping, poor bone quality, difficult angle, and/or excess torque applied.
 
Event Description
A company representative reported that an unspecified number of events in which the serrato screw fractured the pedicle during insertion.No information is currently available regarding the number of occurrences, the length of any resulting surgical delays, and how or if each surgery was completed.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8928082
MDR Text Key174723682
Report Number3005525032-2019-00073
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_SPN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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