MAUDE Adverse Event Report: DEPUY SPINE INC SKY 2 LEVEL PLTE 32MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	186802032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Vivigen: it was reported that an adverse event of increased (pre-existing) low back pain, post-operatively (date of onset: (b)(6) 2018).Study subject 16-010.

• Brand Name: SKY 2 LEVEL PLTE 32MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7296775
• Report Number: 1526439-2018-50166
• Device Sequence Number: 2273900
• Product Code: KWQ
• UDI-Device Identifier: 10705034133683
• UDI-Public: 10705034133683
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 186802032
• Device Lot Number: 134776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/26/2018
• 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: 63 YR