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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS UCSS SCREW SET

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WARSAW ORTHOPEDICS UCSS SCREW SET Back to Search Results
Catalog Number G873H136
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2020
Event Type  Injury  
Manufacturer Narrative
This part is not approved for use in the united states; however a like device catalog #: 873-136, 510k #: k003928 and udi #: (b)(4) was cleared in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.X-ray review results: a post-op image for an odontoid screw/c2 fixation is provided.The bottom of the screw extends out of the c2 body a little bit and image quality makes it difficult to see the apposition of the dens to vertebral body.By report, the surgical technique was incorrect, no hardware failure was identified.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient presented with odontoid process fracture; and underwent a surgery at c2 using nakanishi method.Intra-op, in order to determine the screw length, when an attempt was made to measure with a depth gauge, it was noticed that the engraved position of the guide wire was wrong.This revealed that the guide wire was inserted in the opposite direction.The direction of inserting guide wire was wrong, and the blunt side without the thread was inserted to the vertebra body.The surgeon managed to determine the screw length with the guide wire as it was and the screw was placed.However, screw insertion was not at the position that the surgeon expected.Moreover, bone fragment was pushed by wrong use of the surgeon, and the fracture line deviated.Although no patient complications were reported, there is a possibility of considering a re-operation due to the imperfection of reduction.The procedure was delayed by less than 60 minutes as a result of this event.
 
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Brand Name
UCSS SCREW SET
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9989736
MDR Text Key189243745
Report Number1030489-2020-00471
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/23/2020
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? Yes
Device Operator Health Professional
Device Catalogue NumberG873H136
Device Lot Number0640075W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2020
Initial Date FDA Received04/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/16/2018
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;
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