MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	5011327
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion at l5-s1 due to lumbar canal stenosis.Intra-op, after the cage was inserted and rotated, the physician removed the inserter to check, and it was found that the cage was rotated too much.Then, while trying to rotate the cage back, the cage could not be gripped with the inserter again.The cage was then removed with a hospital owned instrument; and it was found that the threaded part of the cage was stripped.Hence, a new cage was inserted in its place.There was a delay of less than 60 minutes due to this event.No patient complications were reported.Doctor admitted his mistake for having the cage over-inserted forcibly in a place where the intervertebral disc space was narrow.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8705033
• Report Number: 1030489-2019-00634
• Device Sequence Number: 2386995
• Product Code: MAX
• UDI-Device Identifier: 00643169677609
• UDI-Public: 00643169677609
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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 Number: 5011327
• Device Lot Number: H5401318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 68