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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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MDT PUERTO RICO OPERATIONS CO, MED REL INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Model Number G3600315
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
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
Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of dislocation fracture at c3/c4, undergoing a spinal therapy.It was reported that, even though the counter torque was pushed in firmly at the time of final tightening, idling occurred.After that, the same event occurred even though the driver shaft was changed.The set screw stripped at final tightening.In the 8 units of set screws in total, stripping occurred from the second to third one, all the set screws after that stripped without being able to apply the torque properly.After the stripping at the beginning, even though the driver was changed the situation was not improved.Counter torque was used as if mas rod pusher counter torque, the driver was rotated and the method inserting into set screw had been performed properly.The set screw was implanted in a tightened state until just before torque was applied.The doctor commented that he thinks the set screw was applied to the torque in the right direction, but it stripped.There was a delay in the procedure of less than 60 mins.There were no patient symptoms/complications reported.The set screw remains in patient and the driver will be returned.Levels implanted: c2-c5 additional information received.6 set screws have stripped in total, all of the same lot.At final tightening after the force was slowly applied and the driver was rotated, it idled with a crack sound while the torque limiting handle should idle with a click sound usually.The final tightening was unable to be performed because of this driver issue.Therapy details: dislocation fracture c2-5lms it was reported that only the drivers will be returned.
 
Event Description
Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of dislocation fracture at c3/c4, undergoing a spinal therapy.It was reported that, even though the counter torque was pushed in firmly at the time of final tightening, idling occurred.After that, the same event occurred even though the driver shaft was changed.The set screw stripped at final tightening.In the 8 units of set screws in total, stripping occurred from the second to third one, all the set screws after that stripped without being able to apply the torque properly.After the stripping at the beginning, even though the driver was changed the situation was not improved.Counter torque was used as if mas rod pusher counter torque, the driver was rotated and the method inserting into set screw had been performed properly.The set screw was implanted in a tightened state until just before torque was applied.The doctor commented that he thinks the set screw was applied to the torque in the right direction, but it stripped.There was a delay in the procedure of less than 60 mins.There were no patient symptoms/complications reported.The set screw remains in patient and the driver will be returned.Levels implanted: c2-c5 additional information received.6 set screws have stripped in total, all of the same lot.At final tightening after the force was slowly applied and the driver was rotated, it idled with a crack sound while the torque limiting handle should idle with a click sound usually.The final tightening was unable to be performed because of this driver issue.Therapy details: dislocation fracture c2-5lms it was reported that only the drivers will be returned.
 
Manufacturer Narrative
G5: pma / 510(k) #: k163375.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.
 
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.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 a field contact regarding a patient with a pre-operative diagnosis of dislocation fracture at c3/c4, undergoing a spinal therapy.It was reported that, even though the counter torque was pushed in firmly at the time of final tightening, idling occurred.After that, the same event occurred even though the driver shaft was changed.The set screw stripped at final tightening.In the 8 units of set screws in total, stripping occurred from the second to third one, all the set screws after that stripped without being able to apply the torque properly.After the stripping at the beginning, even though the driver was changed the situation was not improved.Counter torque was used as if mas rod pusher counter torque, the driver was rotated and the method inserting into set screw had been performed properly.The set screw was implanted in a tightened state until just before torque was applied.The doctor commented that he thinks the set screw was applied to the torque in the right direction, but it stripped.There was a delay in the procedure of less than 60 mins.There were no patient symptoms/complications reported.The set screw remains in patient and the driver will be returned.Levels implanted: c2-c5 additional information received.6 set screws have stripped in total, all of the same lot.At final tightening after the force was slowly applied and the driver was rotated, it idled with a crack sound while the torque limiting handle should idle with a click sound usually.The final tightening was unable to be performed because of this driver issue.Therapy details: dislocation fracture c2-5lms it was reported that only the drivers will be returned.
 
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Brand Name
INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO, MED REL
road 909, km. 0.4., barrio mar
humacao PR 00792
MDR Report Key10732719
MDR Text Key217719764
Report Number2647346-2020-00035
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,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG3600315
Device Catalogue NumberG3600315
Device Lot NumberH5546293
Was Device Available for Evaluation? No
Date Manufacturer Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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