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

Catalog Number	X0605267
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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.Multiple products were reported but it is unknown which caused the reported event.Product , lot , quantity , udi , 510k.7893035 , w08f1798, 2 , (b)(4), k052609; 7896545 , 950828 , 4 , (b)(4), k050809.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure: posterior lumbar interbody fusion it was reported that post-op, patient complains of low back pain with bilateral extremity pain.Treatment included trigger point injection of the superior posterior iliac crest on right.Injection contained 4 cc lidocaine and 1 cc depo medrol.Probable relationship to interbody device.

• Brand Name: CAPSTONE 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: 7444970
• Report Number: 1030489-2018-00572
• Device Sequence Number: 16586712
• Product Code: MAX
• UDI-Device Identifier: 00885074502397
• UDI-Public: 00885074502397
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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 Catalogue Number: X0605267
• Device Lot Number: 3120866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/19/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 89