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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number UNK_SPN
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
Device return status unknown.
 
Event Description
It was reported that a reflex-hybrid bone screw could not be final locked with a reflex-hybrid plate intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using an alternatively available screw which was able to be final locked.This report captures the plate.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported that reflex hybrid and vboss were used for anterior cervical spine decompression / fixation (c3-6).The surgeon inserted four screws on the reflex plate, but one screw at c3 (variable self-drill screw) did not lock.No further information is available as surgeon not willing to disclose any information.The probable root cause of this event cannot be determine from the information provided.If more information is received, this complaint will be reopened and updated.Per the risk file, contributing factors may be: device interference with other instruments/implants insufficient visibility into wound site previously damaged/deformed instruments/implants used insufficient feedback incorrect depth/trajectory/alignment/positioning hard bone quality too much torsional force applied to insert the screw what damaged the screw head and contributed to difficulty with locking.H3 other text : device remains implanted in patient.
 
Event Description
It was reported that a reflex-hybrid bone screw could not be final locked with a reflex-hybrid plate intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using an alternatively available screw which was able to be final locked.This report captures the plate.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key11656843
MDR Text Key245135563
Report Number0009617544-2021-00061
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
PMA/PMN Number
K040261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/16/2021
Initial Date FDA Received04/13/2021
Supplement Dates Manufacturer Received06/30/2021
Supplement Dates FDA Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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