MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2991022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
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.Following products were also reported in the event: no.Product qty lot 510k 1 2991022 1 h5118852 k073291 00613994291004 3 7893050 1 0082307w k052609 00613994168894 4 7893060 1 0244750w k052609 00613994168917 5 7226550 3 na k050809 00885074362915 6 7226535 1 na k050809 00885074362885 7 7226545 1 na k050809 00885074362908 8 7225545 1 na k050809 00885074362762 although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Level: l3-l5 procedure: open transforaminal interbody fusion it was reported that post-op, dural tear occurred.Small punctate dural rent occurred just below take off of l5 nerve root.Dural tear was repaired during index surgery, surgery was ¿repaired with 6-0 prolene suture and closed with duragen¿.Patient outcome: resolved.

• Brand Name: CAPSTONE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7478378
• Report Number: 1030489-2018-00630
• Device Sequence Number: 11043963
• Product Code: MAX
• UDI-Device Identifier: 00613994291004
• UDI-Public: 00613994291004
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 05/19/2022
• Device Catalogue Number: 2991022
• Device Lot Number: H5118852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 05/01/2018
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 183