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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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WARSAW ORTHOPEDICS CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 6430530
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3/4/5 tlif due to lumbar stenosis.It was reported that the set screw tightening (including temporary fixation) could not be performed.The screw was re-inserted; a new set screw was tried, but final tightening could not be done.The orientation of the tightening was checked and changed several times and the final tightening was carried out.It is presumed that the screw head was unfastened there was no patient symptom reported.There were no further complications reported regarding the event.
 
Manufacturer Narrative
H3: product analysis :part # 6430530.Lot # 0839130w.Visual and optical examination revealed thread crest/flank damage; this damage appears to have initiated at or near the start of the thread and is evident around the damaged portion of the thread.The break off portion of the screw was still attached.Functional inspection confirmed the set screw was not able to be threaded into the head of the bonescrew.This type of damage is consistent with misalignment set screw threads during construct assembly.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
CD HORIZON® SPINAL SYSTEM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14521077
MDR Text Key292794420
Report Number1030489-2022-00500
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169545281
UDI-Public00643169545281
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6430530
Device Catalogue Number6430530
Device Lot Number0839130W
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2021
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 Age57 YR
Patient SexMale
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