• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC SOFAMOR DANEK USA, INC; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number SEE H10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
The following products have been used in the surgery: part#: p1603lii; lot#: m111501aaf; pma#: p000058; udi#: (b)(4), qty#: 2.Part#: 5540030; lot#: h5406110 ; 510k#: k113174; udi# (b)(4), qty#: 8.Part#: 4011022; lot#: 46ak; 510k#: k120368; udi#: (b)(4) qty#: 1.Part#: p1603mgs; lot#: cccn16l4; 510k#: k082166; udi#: (b)(4), qty#: 2.Part#: 1553201080; lot#: 0514330w; 510k#: k113174; udi#: (b)(4), qty#: 1.Part#: 55410007545; lot#: 0217237w; 510k#: k113174; udi#: (b)(4), qty#: 4.Part#: 55840007545; lot#: h5282748; 510k#: k113174; udi#: (b)(4), qty#: 2.Part#: 55840006545; lot#: 0617572w; 510k#: k113174; udi#: (b)(4), qty#: 2.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
2020-july-21, (b)(4) (sdy, rep): the information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient with stenosis with preoperative instability, recurrent disc herniation, concomitant lumbar degenerative deformity (cobb angle < or equal to 30 degrees).It was reported that there was a left foot dysesthia noted at 24 month visit.Describe the additional surgical procedure: acute epidural hematoma surgery: surgeon identified compressive hematoma at l3-l4 and l4-l5 levels and was able to clear out around the l4 nerve root and ensure that it was fully free.Number of levels treated: l3/l4, l4/l5 patient details: randomization assignment: 6mg of rhbmp-2 initial surgery date: (b)(6) 2018.Site relatedness assessment: this event was not related to any devices and surgical procedure used.Sponsor relatedness assessment: this event was possibly related with the infuse kit, mgs kit, interbody device, multiaxial screws, rods, set screws and not related to the procedure and surgical procedure used.Outcome: pending date of diagnosis as related to subjects cancer: (b)(6) 2020 date of pathology report: (b)(6) 2020 cancer results: 3/12 positive for adenocarcinoma; the left mid lateral and left medial showed gleason 4+4=8 prostate cancer and the right base medial showed gleason 3+3=6 prostate cancer.Location / type of cancer: prostate cancer records pending family history of cancer: na lab work: yes lab date: (b)(6) 2019 lab result: elevated psa at 4.25 medications taken within 30 days of cancer diagnosis: na treatment group: group 2 - infuse 6 + mastergraft + local bone seriousness assessment: non-serious patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2019.Patient came for follow up visit on (b)(6) 2020.
 
Manufacturer Narrative
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.
 
Event Description
The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient with stenosis with preoperative instability, recurrent disc herniation, concomitant lumbar degenerative deformity (cobb angle or equal to 30 degrees).It was reported that there was a left foot dysesthia noted at 24 month visit.Describe the additional surgical procedure: acute epidural hematoma surgery: surgeon identified compressive hematoma at l3-l4 and l4-l5 levels and was able to clear out around the l4 nerve root and ensure that it was fully free.Number of levels treated: l3/l4, l4/l5 patient details: randomization assignment: 6mg of rhbmp-2 initial surgery date: on (b)(6) 2018.Site relatedness assessment: this event was not related to any devices and surgical procedure used.Sponsor relatedness assessment: this event was possibly related with the infuse kit, mgs kit, interbody device, multiaxial screws, rods, set screws and not related to the procedure and surgical procedure used.Outcome: pending date of diagnosis as related to subjects cancer: on (b)(6) 2020, date of pathology report: on (b)(6) 2020 cancer results: 3/12 positive for a denocarcinoma; the left mid lateral and left medial showed gleason 4+4=8 prostate cancer and the right base medial showed gleason 3+3=6 prostate cancer.Location / type of cancer: prostate cancer records pending family history of cancer: na lab work: yes lab date: on (b)(6) 2019; lab result: elevated psa at 4.25 medications taken within 30 days of cancer diagnosis: na treatment group: group 2 - infuse 6 + mastergraft + local bone seriousness assessment: non-serious patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2018.Patient came for follow up visit on (b)(6) 2019.Patient came for follow up visit on (b)(6) 2020.Ae of left foot dysesthia is being combined with ae for l5-s1 stenosis and will be captured as a symptom of the stenosis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10395575
MDR Text Key202948377
Report Number1030489-2020-01082
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/01/2019
Device Catalogue NumberSEE H10
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight98
-
-