MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	54850015545
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/09/2016
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.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.
Event or Problem Description
Procedure: transforaminal lumbar interbody fusion levels involved: l4-5 it was reported that intra-op, the screw went in to iliac vein.The general surgeon had to go through stomach to retrieve the screw.The patient lost lots of blood.The surgeon had to open the stomach to retrieve the screw and stop bleeding.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6220772
• Report Number: 1030489-2017-00022
• Device Sequence Number: 13554936
• Product Code: NKB
• UDI-Device Identifier: 00643169491236
• UDI-Public: 00643169491236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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 Catalogue Number: 54850015545
• Device Lot Number: H5167699
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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