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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

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MEDTRONIC SOFAMOR DANEK USA, INC PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, Back to Search Results
Model Number 2161001
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/09/2021
Event Type  malfunction  
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for scoliosis, degeneration thoracic and lumbar spine.Procedure or therapy performed was olif.It was reported that the tip of the threaded shaft broke off during implantation of a cage at the disc space of l3/4 during an olif.During the posterior portion of the surgery, the tip of the instrument bent.The cage was implanted successfully.The tip of the threaded shaft remains inside the implant in the patient.Nothing happened to the patient.There were no symptoms reported.There were no further complications reported regarding the event.No additional surgery is planned.The shaft tip was safely secured inside the implant.There was no way to remove it.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
D4: lot #nm18g004 has been updated.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.
 
Manufacturer Narrative
Product analysis product id: 2161001 lot no.: nm18g004 visual and optical inspection confirmed the instrument is broken several threads down from the distal tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of fatigue consistent with overload.This type of damage is consistent with bend stress overload.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
PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key13140357
MDR Text Key288817897
Report Number1030489-2022-00001
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00643169639607
UDI-Public00643169639607
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152277
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,Followup
Report Date 05/17/2022
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 Number2161001
Device Catalogue Number2161001
Device Lot NumberNM18G004
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2021
Initial Date FDA Received01/03/2022
Supplement Dates Manufacturer Received01/04/2022
04/26/2022
Supplement Dates FDA Received01/04/2022
05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age68 YR
Patient SexMale
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