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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC VERTEX RECONSTRUCTION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC VERTEX RECONSTRUCTION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number MSB_UNK_CROSSLINK
Device Problems Break (1069); Material Deformation (2976)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/06/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during intra-op, rod crosslink stripped.Screw stripping occurred collectively on the left side of the rod crosslink.The rod crosslink broke and could not be removed, the operation was continued and completed without removing the broken rod crosslink.Fragments of the instrument remained in the patient's body.Patient complications were unknown.There was a delay in overall procedure for less than one hour.Levels implanted: c3/4/5.Procedure involved was cervical posterior fusion.
 
Manufacturer Narrative
B1,h1: correction was made for product problem (initial report was for serious injury- not applicable to this event).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
VERTEX RECONSTRUCTION SYSTEM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10354738
MDR Text Key202087157
Report Number1030489-2020-01017
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMSB_UNK_CROSSLINK
Device Catalogue NumberMSB_UNK_CROSSLINK
Device Lot NumberMSB_UNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/06/2020
Initial Date FDA Received08/03/2020
Supplement Dates Manufacturer Received08/12/2020
Supplement Dates FDA Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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