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

Catalog Number	4001227
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of 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 l3/4 and l4/5.During surgery, spacer implanted at l4-l5 was broken.There are fragments of spacer at l4-5 still inside the patient.No patient complications were reported.No revision surgery was scheduled.

• Brand Name: CAPSTONE CONTROL 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: 6982690
• Report Number: 1030489-2017-02264
• Device Sequence Number: 18962373
• Product Code: MAX
• UDI-Device Identifier: 00643169109766
• UDI-Public: 00643169109766
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 05/09/2024
• Device Catalogue Number: 4001227
• Device Lot Number: 44BZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1