MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Pre-operative diagnosis: spinal canal stenosis type of procedure: oblique lumbar interbody fusion levels implanted: l2-5 it was reported that during surgery, when the surgeon inserted the cage using the inserter and hammer, the screw part of the cage got shaved.The inserter could not be attached to the cage again.No fragment of the broken product remained inside the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Visual and microscopic examination identified the threads of the inserter interface to be stripped off, with evidence of deformation on the face of the implant or hole diameter.The above observations are consistent with significant impact during attempted assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 6438401
• Report Number: 1030489-2017-00706
• Device Sequence Number: 18957695
• Product Code: MAX
• UDI-Device Identifier: 00643169190726
• UDI-Public: 00643169190726
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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 Expiration Date: 11/10/2024
• Device Catalogue Number: 4986050
• Device Lot Number: 59CW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 07/28/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61