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

Catalog Number	9010000849
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with lumbar spinal canal stenosis and lumbar spondylolisthesis underwent posterior spinal fusion at l3-5.Intra-op, after insertion of pedicle screws at left side of l3-5, the surgeon attempted to attach rod to rod inserter but the rod inserter's gripping force was not enough so the tension knob was adjusted.After the adjustment, when the surgeon tried to perform rod insertion the rod came off from it, although he did not lift up the latch lever of the inserter.The came off rod was removed.Rod was again tried to be attached to the inserter at right side but same event happened again.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: "functional evaluation with the returned inserter and associated rod confirmed inability to firmly attach rod.Per the event description "the surgeon adjusted the tension nob after he attached the rod to the inserter" this is expressly warned against in the surgical technique which states: "note: when the clasp is open, a t25 driver may be used to adjust the tension, if needed" visual and functional evaluation identified disassembly of the retaining ring, thus preventing proper tension of the rod.The above observations suggesting the tension adjustment of the inserter with the rod in place may have initiated the inserter disassembly, and the subsequent event.".
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: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6208022
• Report Number: 1030489-2016-03589
• Device Sequence Number: 738421
• Product Code: KWP
• UDI-Device Identifier: 00643169359987
• UDI-Public: 00643169359987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162494
• 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): 02/15/2017

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: 9010000849
• Device Lot Number: RS15D013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided; 02/15/2017
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 03/15/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD
• Patient Age: 71 YR