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

Catalog Number	2991226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.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
Pre-op diagnosis: l4/l5 disc bulging, ligamentum flavum thickening and spinal stenosis.2 types of diabetes mellitus.Hypertension.Right tibia fracture after operation.Otitis media.Sinus bradycardia.Procedure used: spinal internal fixation system for open lumbar fusion surgery it was reported that the patient underwent a posterior lumbar interbody fusion.Post-op, on (b)(6) 2017 the wound was oozing exudate showing suspicion of infection.On (b)(6) 2017, wound debridement was performed.

• 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: 7062548
• Report Number: 1030489-2017-02398
• Device Sequence Number: 102445
• Product Code: MAX
• UDI-Device Identifier: 00613994290953
• UDI-Public: 00613994290953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073291
• 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
• Report Date (Section B): 11/28/2017

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: 03/17/2025
• Device Catalogue Number: 2991226
• Device Lot Number: H5345856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2017
• Initial Report FDA Received Date: 11/28/2017
• 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: 73 YR