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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 2161001
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
Product was not 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
It was reported that the patient was pre-operatively diagnosed with degenerative disc disease at l4/5 and underwent oblique lumbar interbody fusion at l4/5.During the surgery, the tip of the threaded inserter broke.During insertion under x-ray, when the cage was approximately ¾th of the way across the disc space, the inserter became detached from the implant.Upon inspection of the inserter it was clear that the tip has broken off from the internal threaded inserter.It has broken off flush with the articulating section of the implant.The surgeon tried to use needle holders to remove the broken fragment but was unable to remove.The product came in contact with the patient.Fragment of the products were remained in the patient.No patient symptoms or complication were reported.No additional treatment or surgery performed as the result of the event.
 
Manufacturer Narrative
Radiographic image review: post-op x-rays for l4-l5 olif show satisfactory placement of interbody graft.By report, the threaded inserter broke of in the interbody graft.In the provided images, there are no metal fragments outside interbody space in the field of view.The tip is presumably still in the interbody graft and should not interfere with the performance of the device.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis visual review confirmed the instrument is broken several threads down from the tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of torsion or fatigue.There is a shear lip that is consistent with bend stress overload.Conclusion: the above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIVOX OBLIQUE LATERAL SPINAL SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8202640
MDR Text Key131602788
Report Number1030489-2018-01707
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00643169639607
UDI-Public00643169639607
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K152277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/22/2019
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 Catalogue Number2161001
Device Lot NumberNM18G004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received01/15/2019
02/26/2019
Supplement Dates FDA Received02/13/2019
03/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
Patient Weight77
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