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

Catalog Number	4986245
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.However product images were submitted which appear to display implant with stripped threads with deformation on the face of implant.
Event or Problem Description
It was reported that patient with thoracic ossification of the yellow ligament and ossification of posterior longitudinal ligament underwent oblique lumbar interbody fusion at l2/3.Intra-op, when surgeon was inserting cage at l2/3 using inserter, the cage came off from the inserter.The surgeon couldn't add more impact to the cage, so the cage was removed using forceps.Excessive force was applied on inserter during cage insertion.Threads of the cage were shaved.The surgeon tried to reinsert the cage but couldn't insert it.Another cage was opened and used.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis :visual, optical, and microscopic examination of the implant identified asymmetrical witness mark on the top face of the implant and stripped internal threads in the center threaded hole.These observations are consistent with significant impact during attempted implantation.
Additional Manufacturer Narrative
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: 6412507
• Report Number: 1030489-2017-00559
• Device Sequence Number: 10946920
• Product Code: MAX
• UDI-Device Identifier: 00643169190689
• UDI-Public: 00643169190689
• 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): 05/17/2017

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: 03/03/2024
• Device Catalogue Number: 4986245
• Device Lot Number: 03BG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided; 05/17/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/18/2017; 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: 32 YR
• Patient Weight: 119