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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 54410005545
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The information was received from health care provider via a manufacturer representative regarding a patient with ddd and face arthritis for posterior lumbar fusion spinal therapy at l4-5.It was reported that the head up of the pedicle screw broke upon final tightening of the set screw.There was no patient symptoms or complications as a result of this event.
 
Manufacturer Narrative
Part# 54410005545 lot# h10c5718 visual review confirms one side of fixed angle screw head is broken off and not returned for analysis.The unbroken side of the fas head reveals fas head thread flank and crest damage.On the broken side fracture appears to have initiated near the base of the thread root and propagated cross-sectional through the implant; the direction of material deformation and fracture is consistent with bend stress overload.The above observations are consistent with suggest bend stress overload during intraoperative 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)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12352303
MDR Text Key267619953
Report Number1030489-2021-01066
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00613994586681
UDI-Public00613994586681
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/10/2022
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 Model Number54410005545
Device Catalogue Number54410005545
Device Lot NumberH10C5718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/23/2021
Supplement Dates Manufacturer Received12/22/2021
Supplement Dates FDA Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2010
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 Age49 YR
Patient SexFemale
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