MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2990001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
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 was pre-operatively diagnosed with kyphosis; and underwent l2-l3 posterior lumbar interbody fusion, l4-l5 transforaminal lumbar interbody fusion and l4 pedicle subtraction osteotomy.Intra-op, after hammering the first cage at l4-l5, it was noticed that the claw part of the inserter remained in the cage.This was found in the image after the placement of the cage.The physician tried to remove the broken part by suction of blood.When performing suction, the broken part could not be found in the patient¿s body, and the broken part was found missing.It could not be determined if the broken fragment of the instrument remained inside the patient or not.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual exam and microscopic exam show that the upper tab of the instrument is completely sheared off and the threaded inner shaft is missing.The broken piece was not returned for the analysis.This is consistent with bend stress overload.The hardness of the instrument is within print specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8703552
• Report Number: 1030489-2019-00630
• Device Sequence Number: 2073399
• Product Code: MQP
• UDI-Device Identifier: 00613994803061
• UDI-Public: 00613994803061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103731
• 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
• Report Date (Section B): 08/14/2019

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: 2990001
• Device Lot Number: NM12A017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other