MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK 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	12/06/2016
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 burst fracture at l1,2 underwent th12-l3 posterior spinal fusion.Intra-op, during insertion of rod, the rod inserter could not grip a rod firmly.The surgeon tried to tighten the rod inserter for its gripping force using driver but it could not be tighten then the rod inserter could not grip a rod anymore.There was another surgery that was scheduled using the rod inserter on the same day so that inserter was used in the surgery.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: the inner shaft does not move when the locking lever is moved.The "c" clip that connects the adjusting mechanism to the shaft appears to have come out.It is possible to overload the clip if making tension adjustments while the rod is in place.It appears that the clip may have been overloaded.
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; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6215014
• Report Number: 1030489-2016-03606
• Device Sequence Number: 13676461
• 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): 03/03/2017

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: RS15F010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 03/03/2017
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 03/06/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1