MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7570900
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent percutaneous spinal pedicle screw placement at t11,t12,l2,l3 to fix lumbar fracture at l1.Intra-operatively,the inserter broke.The rod introducer was trapped in the tulip of the pedicle screw and on removal could result in damage to the implanted screw tulip and the rod inserter.Hence, the screw at l3 was left free from set screw insertion for securing the rod at patient's left side.The surgeon made the clinical decision on the remaining construct to secure the fracture.No fragment of the instrument remained in the patient.No patient complications were reported as a result of alleged event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Surgeon bent the item when removing.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8980122
• Report Number: 1030489-2019-01001
• Device Sequence Number: 10853892
• Product Code: KWP
• UDI-Device Identifier: 00613994302748
• UDI-Public: 00613994302748
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7570900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1