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

Catalog Number	9392510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Although it is unknown if the device contributed to the reported event we are filing this mdr for notification purposes only.
Event or Problem Description
It was reported that patient underwent posterior spinal disc decompression and fusion.Post-op, the patient developed infection after the surgery.Patient is getting treated with anti-infective therapy.The product still remained in patient's body.No product malfunction was reported.It is unclear that the implanted product contributed to the patient's infection or not.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT 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: 6553397
• Report Number: 1030489-2017-01152
• Device Sequence Number: 557186
• Product Code: MAX
• UDI-Device Identifier: 00613994187482
• UDI-Public: 00613994187482
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K094025
• 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,Followup
• Report Date (Section B): 04/14/2017

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 Expiration Date: 05/04/2023
• Device Catalogue Number: 9392510
• Device Lot Number: H5182922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: Hospitalization; Other
• Patient Age: 65 YR