MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	25740018590
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	07/10/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with kyphosis and underwent posterior fusion at l2/s2ai.Post-op, the wound opened due to some reasons after the operation , the patient underwent continuous cleaning.It was confirmed that the screw backed out when performing x-ray and ct.Since the wound was open and it was able to remove the product on the spot, revision fusion before wound closure was requested, so revision fusion was performed.Replacement was performed and the item was discarded.There was infection and the patient received re-operation several times.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® BALLAST¿ SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7766751
• Report Number: 1030489-2018-01112
• Device Sequence Number: 14007793
• Product Code: NKB
• UDI-Device Identifier: 00643169414921
• UDI-Public: 00643169414921
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 25740018590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: Other; Required Intervention