MAUDE Adverse Event Report: DEPUY SPINE INC SKY 2 LEVEL PLTE 30MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	186802030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Spine revision: (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2017.Post initial fixation patient has sustained a fall, which has led to further injury to cervical spine.Hardware removed to try and alleviate symptoms associated with new injury.(b)(6).Spd: product code 186802030: 30 mm 2 level skyline x 1 = discarded.Spd: product code 186850012: 12 mm vasd screws x 6 = discarded.

• Brand Name: SKY 2 LEVEL PLTE 30MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7309875
• Report Number: 1526439-2018-50198
• Device Sequence Number: 2274162
• Product Code: KWQ
• UDI-Device Identifier: 10705034133676
• UDI-Public: 10705034133676
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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: 186802030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/02/2018
• 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: Required Intervention