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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MSD DEGGENDORF MFG CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 2926250
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2020
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
It was reported that the patient presented with lumbalgia at l3-l4 and l4-l5; and underwent oblique lumbar interbody fusion at l2-l3 and l3-l4.Intra-op, the cage broke.No fragment of the broken cage remained inside the patient.No patient complications were reported as a result of this event.
 
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Brand Name
CLYDESDALE SPINAL SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MSD DEGGENDORF MFG
wertstrasse 17
deggendorf 94469
DE  94469
MDR Report Key9811904
Report Number1030489-2020-00295
Device Sequence Number643283
Product Code MAX
UDI-Device Identifier00613994972477
UDI-Public00613994972477
Combination Product (Y/N)N
Initial Reporter CountryPM
PMA/510(K) Number
K113528
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/10/2020
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
Operator of Device Health Professional
Device Catalogue Number2926250
Device Lot Number35JE
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date03/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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