MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	8657008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Product image review: submitted images appear to display distal tip of inserter broken off.X-ray review: intra-op x-rays demonstrate a returned piece of a distractor instrument used for disc space preparation and placement of an interbody spacer.Likely cause is excessive manipulation of the instrument in the disc space creating shear forces excessive to the instruments rated strength.
Event or Problem Description
It was reported that intra-op, a large part of the distractor trial broke off in the disc space of patient's body and could not be retrieved.
Additional Manufacturer Narrative
Product analysis: visual examination of the returned instrument identified tip and inner shaft fracture approximately 20 mm from the distal tip.Microscopic examination of the fracture surface identified a fairly ductile fracture surface with adjacent material deformation consistent with bend stress overload.

• Brand Name: ELEVATE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6683789
• Report Number: 1030489-2017-01650
• Device Sequence Number: 19325688
• Product Code: MAX
• UDI-Device Identifier: 00643169432246
• UDI-Public: 00643169432246
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8657008
• Device Lot Number: EM16B001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 08/30/2017
• 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
• Patient Age: 56 YR