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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ELEVATE¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

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WARSAW ORTHOPEDICS ELEVATE¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, Back to Search Results
Model Number 7770723
Device Problem Break (1069)
Patient Problems Stenosis (2263); Ambulation Difficulties (2544)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient spinal therapy for degenerative kyphoscoliosis.It was reported that at l3 / 4 plif, the operator noticed something unusual during the cage insertion, and when the cage was pulled up, the peek part was damaged.It had been confirmed before the insert that the tip of the cage was closed, and all broken fragments were collected.There was patient involved in the event and no symptoms were reported.(b)(6) 2021 (rep): additional information was received via manufacturer representative that the reported product came in contact with the patient.The implant date and explant date is (b)(6) 2021.The peek joint part at the posterior of the cage broke on one side.The two surgeries were done on same day.The patient had difficulty standing or walking and stenosis were intercurrent.There was a revision surgery/ in- patient or prolongation of existing hospitalization/ additional surgery/ delay in overall procedure time.
 
Manufacturer Narrative
H3: product analysis:part 7770723, lot # 0758071w visual and optical inspection revealed the one of the tabs/ears of the implant has been broken off and the other has been bent and cracked.There is no damage present on the nose, ribs or body of the implant.It appears the damage was done during the insertion process.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
ELEVATE¿ SPINAL SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
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 Key11918909
MDR Text Key263373296
Report Number1030489-2021-00728
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7770723
Device Catalogue Number7770723
Device Lot Number0815031W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
Patient SexFemale
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