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

Catalog Number	2991026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown if the device led to the event, we are filing this report for notification purposes.Allergic reaction, acne, worsening of asthma.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
Implant date: (b)(6) 2010 (month and year valid) it was reported that on an unknown date, post-op, patient suffered with severe scalp acne, allergic reaction and worsening of asthma.Patient stated she was aware of nickel allergy prior to the surgery.

• 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: 6375594
• Report Number: 1030489-2017-00452
• Device Sequence Number: 658614
• Product Code: MAX
• UDI-Device Identifier: 00613994290991
• UDI-Public: 00613994290991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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 Catalogue Number: 2991026
• Device Lot Number: H10G3448
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS, RODS, SET SCREWS
• Outcome Attributed to Adverse Event: Other