MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.647.836
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during an anterior cervical fusion on (b)(6) 2018, the surgeon was not able to fully seat the titanium cervical spine screw self -drilling/variable angle to engage the locking mechanism.After using supplied awl, the surgeon attempted multiple times using the angled and straight screwdriver to fully seat the screw within locking zone (past the locking button on the plate).The surgeon tried to use the screw removal screwdriver in an attempt to get better purchase when trying to fully engage the screw.Surgeon was unable to do so and felt confident in leaving the screw 1mm proud.Surgeon mentioned that the screw was not moving, and he didn¿t want to attempt to remove the screw beyond what had been attempted.Surgeon did not want to cause more harm in trying to remove the screw.The rest of the operation continued, and surgeon was satisfied.There was an unknown surgical delay.There was no patient consequence.Concomitant devices: screwdriver (part: unknown, lot: unknown, quantity: unknown), plate (part: unknown, lot: unknown, quantity: unknown).This report is for a 3.7mm titanium (ti) cervical spine screw.This is report 1 of 1 for (b)(4).

• Brand Name: 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 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: 8252644
• Report Number: 2939274-2019-55878
• Device Sequence Number: 1439227
• Product Code: OVE
• UDI-Device Identifier: 10705034751368
• UDI-Public: (01)10705034751368
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: Health Professional
• Device Model Number: 04.647.836
• Device Catalogue Number: 04.647.836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/16/2019
• Patient Sequence Number: 1