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

Catalog Number	7570901
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
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.(b)(4) if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that intra-op, the extender (with the inner sleeve inside) could be turned forward only till 'load', but then it became hard to turn it further.It could be turned backward to 'eject' but not forward.Different inner sleeves were tried with this particular extender but the same problem occurred every time.Another extender was used to complete the surgery.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual review confirmed some deformation at the tip of the extender where the sleeve engages.Functional evaluation with a sample inserter sleeve found the instrument able to be engaged into the extender without issue.After visual and functional evaluation, the instrument appears to be capable of performing its intended function.There was no fault found with the product.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: 8662045
• Report Number: 1030489-2019-00592
• Device Sequence Number: 19378813
• Product Code: KWP
• UDI-Device Identifier: 00613994302762
• UDI-Public: 00613994302762
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• PMA/510(K) Number: K122862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 7570901
• Device Lot Number: RS11H008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1