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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MEDTRONIC SOFAMOR DANEK CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 4986050
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/28/2017
Type of Reportable Event Malfunction
Additional 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 or Problem Description
Pre-op diagnosis: spinal canal stenosis procedure: oblique lumbar interbody fusion levels operated: l2/3, l3/4 it was reported that during surgery, the grasping mechanism of the cage broke.It was confirmed that inserter could no longer grasp the cage when detaching the cage from it.No narrowing of the intervertebral disc was observed, and the cage was seemed to be inserted parallel against the intervertebral disc.Patient complications were reported as unknown.
 
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Brand Name
CLYDESDALE PTC SPINAL SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
MDR Report Key7147187
Report Number1030489-2017-02568
Device Sequence Number11126619
Product Code MAX
UDI-Device Identifier00643169190726
UDI-Public00643169190726
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133205
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/27/2017
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
Operator of Device Health Professional
Device Catalogue Number4986050
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2017
Initial Report FDA Received Date12/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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