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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO XPANDER; ARTHROSCOPE

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MEDTRONIC MEXICO XPANDER; ARTHROSCOPE Back to Search Results
Model Number K08A
Device Problem Material Rupture (1546)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
Report source foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider via manufacturing representative regarding patient with l4 vertebral fracture suggested for spinal therapy.Event occurred intra-op.It was reported while balloon was inflating and without the pressure being high enough (around 250-300psi) there was a loss of resistance, the customer removed the balloon and rapture was noticed.There was delay in overall procedure.No patient symptoms reported.No further complications reported.Device is being returned.
 
Manufacturer Narrative
H3: product analysis: part # k08a, lot # 218190068 visual and functional inspection revealed the balloon has been damaged.The damage is a tear in the upper portion of the balloon.This type of damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.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
XPANDER
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key10789776
MDR Text Key214780809
Report Number9612164-2020-04244
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00763000025588
UDI-Public00763000025588
Combination Product (y/n)N
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/08/2021
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 Expiration Date08/02/2021
Device Model NumberK08A
Device Catalogue NumberK08A
Device Lot Number218190068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/05/2020
Supplement Dates Manufacturer Received06/18/2021
Supplement Dates FDA Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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