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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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MEDTRONIC SOFAMOR DANEK USA, INC INFINITY; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Model Number G3602537
Device Problem Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient with a pre-operative diagnosis of fracture - dislocation on c5/6 being implanted with a cross link device for c5/6 posterior decompression and fusion procedure.It was reported that after the screw and rod were placed, cross link was placed.The set screw stripped at the final torque out.There was a point that the space between the rod was narrow and the universal counter could not be used, but the rod was gripped with the rod holder and the counter was performed.The sales person in charge understands that screw stripping was likely to occur, and checked the operator's operation at the time of torque out, but there was no problem with instrument operation.Since driver attrition was also considered, the driver was replaced, but stripping occurred, so the doctor thought that the event was caused by the implant.An implant with the same lot and same size was newly opened and used.There was a delay in the procedure by less than 60 mins due to the cross link replacement operation.No health damage in the patient was reported.No further complications were reported regarding the event.Update: after final tightening of 4 units of screws, the set screws on both sides of the reported cross link stripped at the final tightening with the same driver.Therefore, they were removed, and a new one was opened, and it was tightened with another driver.The driver was a long-term loaned product.Doctor's comment: it is the problem of implant product.
 
Manufacturer Narrative
H3: visual and optical inspection revealed the female hex of the set screw have been damaged.The hex edges have been rounded and stripped.This type of damage is consistent with torsional overload additional information : e1.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.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient with a pre-operative diagnosis of fracture - dislocation on c5/6 being implanted with a cross link device for c5/6 posterior decompression and fusion procedure.It was reported that after the screw and rod were placed, cross link was placed.The set screw stripped at the final torque out.There was a point that the space between the rod was narrow and the universal counter could not be used, but the rod was gripped with the rod holder and the counter was performed.The sales person in charge understands that screw stripping was likely to occur, and checked the operator's operation at the time of torque out, but there was no problem with instrument operation.Since driver attrition was also considered, the driver was replaced, but stripping occurred, so the doctor thought that the event was caused by the implant.An implant with the same lot and same size was newly opened and used.There was a delay in the procedure by less than 60 mins due to the cross link replacement operation.No health damage in the patient was reported.No further complications were reported regarding the event.Update: after final tightening of 4 units of screws, the set screws on both sides of the reported cross link stripped at the final tightening with the same driver.Therefore, they were removed, and a new one was opened, and it was tightened with another driver.The driver was a long-term loaned product.Doctor's comment: it is the problem of implant product.The driver had been returned to loaner because it was recognized as a malfunction due to that the screw of the implant product stripped.The driver might be deformed.There was no breakage or stripping in the second driver.There was no damage at all.It was returned to the loaner.
 
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Brand Name
INFINITY
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10383384
MDR Text Key202173450
Report Number1030489-2020-01047
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
PMA/PMN Number
K163375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/10/2020
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 NumberG3602537
Device Catalogue NumberG3602537
Device Lot NumberRM19E010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received12/08/2020
Supplement Dates FDA Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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