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

Catalog Number	4021522
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2017, patient presented with pre-op diagnosis as: spondylolisthesis.For which patient underwent, fusion and transforaminal lumbar interbody fusion (tlif) at levels l4-l5.Intra-op, the cage was placed laterally and went through the anterior ligament.The cage went off the inserter and ended up anteriorly.The patient had to undergo anterior surgery to get the cage out.The inserter had no malfunction.No patient complications were reported.
Additional Manufacturer Narrative
Additional information: product analysis: visual and microscopic examination identified the top approximately ~4 threads of the inserter interface to be stripped, with no evidence of deformation on the face of the implant or hole diameter.The above observations are consistent with significant impact during attempted assembly.

• 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: 6577672
• Report Number: 1030489-2017-01271
• Device Sequence Number: 1049563
• Product Code: MAX
• UDI-Device Identifier: 00643169109087
• UDI-Public: 00643169109087
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Catalogue Number: 4021522
• Device Lot Number: 17CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 07/19/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/16/2017; 09/07/2017
• 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: 41 YR
• Patient Weight: 130