MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.617.816
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Date of event: date of device migration is not known.Additional product code: kwq (b)(4).Date of implant/explant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient is scheduled for a revision procedure on an unknown date due to three (3) 3.0mm titanium cervical spine locking screws 16mm that appear to have backed out of the zero-p natural construct.Patient consequence is unknown.The patient underwent an anterior cervical fusion at an unknown level and was initially implanted with the hardware on an unknown date.Concomitant devices reported: zero-p implant (part number unknown, lot number unknown, quantity unknown), screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) 3.0mm cervical spine locking screw 16mm.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Pt id: (b)(6).Updated concomitant devices.These dates were incorrectly reported as (b)(6) 2018 in the initial report (b)(4).The correct date is (b)(6) 2018.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 further reported that post-operative of the initial implant, routine postoperative follow-up revealed screws backing out of construct when plain film x-rays were analyzed.Patient was scheduled for revision surgery which involved removal of screws and reimplantation of new screws.Patient underwent a revision procedure on (b)(6) 2018 due to three (3) 3.0mm titanium cervical spine locking screws 16mm that had backed out of one (1) of the two (2) implanted zero-p natural constructs (8mm or 9mm).The screws were removed from the one (1) cage and both cages remained implanted.The plate remained implanted.New screws were implanted into the existing cage under intraoperative fluoroscopy.Revision surgery was nominal and there was no surgical delay.Procedure was completed successfully.Concomitant devices reported: zero-p implant (part # unknown, lot # unknown, quantity # unknown), 3.0mm titanium cervical spine locking screw 16mm (part # 04.617.816, lot # unknown, quantity # 1).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7252607
• Report Number: 2939274-2018-50552
• Device Sequence Number: 1250449
• Product Code: OVE
• UDI-Device Identifier: 10705034742298
• UDI-Public: (01)10705034742298(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.617.816
• Device Catalogue Number: 04.617.816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/16/2018
• 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