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

Catalog Number	4001127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that patient with lumbar spinal canal stenosis underwent transforaminal lumbar interbody fusion (tlif) at l4-5 on (b)(6) 2017.Reportedly, on (b)(6) 2017, post-op, radicular symptoms on right side at l5 were observed after tlif surgery at l4-5.Revision surgery was scheduled for (b)(6) 2017.Reportedly patient's root was much thicker than the normal patient's and runs transversely.During revision surgery, on (b)(6) 2017, only decompression at right side was performed.The spacer did not malfunction.According to surgeon, the left side of vertebral body was lifted too much, or it was due to compression technique.

• 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: 6359904
• Report Number: 1030489-2017-00429
• Device Sequence Number: 16359062
• Product Code: MAX
• UDI-Device Identifier: 00643169109735
• UDI-Public: 00643169109735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: 4001127
• Device Lot Number: YE45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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
• Patient Age: 79 YR
• Patient Weight: 65