MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EAGLE SWIFT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	183650018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Not returned for evaluation.
Event or Problem Description
The surgeon was removing 2 plates and 8 screws of which 2 screws broke.Effected c3-c7.

• Brand Name: EAGLE SWIFT
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6891437
• Report Number: 1526439-2017-10755
• Device Sequence Number: 125104
• Product Code: KWQ
• UDI-Device Identifier: 10705034095790
• UDI-Public: (01)10705034095790
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K070994
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 183650018
• Device Catalogue Number: 183650018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/25/2017
• Patient Sequence Number: 1
• Patient Age: 61 YR