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

Catalog Number	4986040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	10/11/2018
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.Products from multiple manufacturers were used during the procedure.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
Pre-operative diagnosis for this procedure: lumbar kyphoscoliosis type of procedure or technique used: olif (oblique lumbar interbody fusion) levels implanted: l2/3/4 it was reported that intra-op, after implantation was completed, when performing hemostasis to the bleeding from the end plate of vertebral body, the somatic artery was injured causing blood loss of about 500-600ml.Hemostasis was performed with facility owned tweezer and gauze.The wound was closed by sprinkling the floseal after hemostasis with astriction or cauterization.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No extended hospitalization was required for the patient due to the adverse event.No malfunction was reported for the product; and the injury was not caused due to the product.Posterior fusion was planned to be performed; however no information is available if it was actually performed.

• Brand Name: CLYDESDALE PTC 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: 8050174
• Report Number: 1030489-2018-01460
• Device Sequence Number: 1586133
• Product Code: MAX
• UDI-Device Identifier: 00643169190740
• UDI-Public: 00643169190740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: 4986040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/08/2018
• 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: Required Intervention