MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CAPSTONE PEEK VERT BODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2990822
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient spinal therapy for degenerative spondylolisthesis and stenosis occurred at l4/5/s.It was reported that after performing plif at l5/s with capstone-peek, the rod with lordosis was placed on il and s1, then set screws were attached on l3, l4 and l5 over ari using cantilever technique, after that, the x-ray image was checked and it was found that the capstone-peek on the right side has moved forward.There was no overall delay in procedure and product remains in patient.There was patient involved in the event and no further complications reported regarding the event.Additional information was received on 2020-06-25: after correction with the cantilever technique, it was confirmed that the cage on the right side of l5 was protruding by about 10 mm from the front edge of the vertebral body.The procedure was completed as it was by the dr.'s judgement.No health damage in the patient was reported.Since the position has not been confirmed after the cage was placed, it is unknown exactly whether the event occurred when the cage was placed or after correction.Doctor¿s comments: the cage might be pushed out by cantilever.In the future, the cage will be removed from the anterior side when it backed out.

• Brand Name: CAPSTONE PEEK VERT BODY SPACER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 10287537
• Report Number: 2647346-2020-00011
• Device Sequence Number: 1045739
• Product Code: MAX
• UDI-Device Identifier: 00613994291042
• UDI-Public: 00613994291042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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 Expiration Date: 02/24/2025
• Device Model Number: 2990822
• Device Catalogue Number: 2990822
• Device Lot Number: H5342731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR