MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2990003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
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
Procedure: transforaminal lumbar interbody fusion pre-operative diagnosis: lumbar spinal canal stenosis level: l4-s it was reported that intra-op, breakage of the shaft was confirmed outside the patient's body.The product came in contact with the patient.No product fragments remained in patient.No symptoms or complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection of the threaded inserter did not reveal any non-conformances.Functionally tested the threaded inserter with a sample 2990001 inserter with no issues.No fault found.Inserter is capable of performing its intended function.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7852230
• Report Number: 1030489-2018-01212
• Device Sequence Number: 1938633
• Product Code: MAX
• UDI-Device Identifier: 00613994846266
• UDI-Public: 00613994846266
• 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): 01/14/2019

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: 2990003
• Device Lot Number: NM11M002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1