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

Catalog Number	5484902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
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.
Event or Problem Description
It was reported that the patient, pre-operatively diagnosed with parkinson's disease, underwent posterior fusion surgery.Intra-operatively after the spinal correction using trauma device, the doctor might have tightened a reducer too much using a reduction nut driver.During rod reduction, the ring of the reducer broke.As result of which a part came off from the reducer.The broken one was replaced with another one.The product came in contact with the patient.There were no fragments remaining in the patient.No patient complications reported as the result of this event.
Additional Manufacturer Narrative
Product analysis: visual review confirms instrument disassembly.Microscopic examination of the -05 retaining ring identified defor mation, corner material shearing and shear lines near the top right corner ¿ear¿ of the outer diameter surface of the ring.Witness marks and deformation in ring groove and on the ring itself suggest the retaining ring was initially seated in the ring groove.Dimensional examination of the -02 reducer body groove diameter, (into which the -05 retaining ring is seated), as well as the -05 retaining ring material thickness of the ring was found to be within print specification.The od of the -05 retaining ring found to be undersized.The above observations are consistent with manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON 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: 6577675
• Report Number: 1030489-2017-01272
• Device Sequence Number: 10949919
• Product Code: NKB
• UDI-Device Identifier: 00643169177024
• UDI-Public: 00643169177024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122862
• 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,Followup
• Report Date (Section B): 08/29/2017

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: 5484902
• Device Lot Number: EM13G001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 04/26/2017; 08/29/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR