MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 18MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.618
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided for reporting.(b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.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
It was reported that a patient received one (1) vectra plate and six (6) screws on (b)(6) 2016.The patient experienced tenderness on the back of her neck on an unknown date and upon follow-up visit to the surgeon, discovered the screws had backed out of the plate.The patient was returned to surgery on (b)(6) 2017 for a hardware removal.All implanted devices were removed intact and no issues during revision.The patient did not receive new implants since the wound had healed.The procedure was uneventful with a stable patient outcome.No surgical time delay reported.Concomitant devices reported: vectra plate (part# 04.613.136, lot# unknown, quantity 1).This report is for one (1) 4.0mm ti cerv self-retain screw.This is report 3 of 6 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.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
It was confirmed that the surgery was performed at c4 to c6.

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 18MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7074622
• Report Number: 1000562954-2017-50012
• Device Sequence Number: 16430288
• Product Code: KWQ
• UDI-Device Identifier: 10705034737836
• UDI-Public: (01)10705034737836(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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 Model Number: 04.613.618
• Device Catalogue Number: 04.613.618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 70