MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.617.814
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: kwq.Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2019, the patient underwent hardware removal because the patient complained of pain and dysphasia and the cervical spine locking screw backed out of a zero profile construct at c4/5 level.The surgeon made an incision and pulled out the screw successfully with a pickup.After closing the incision, the patient was repositioned and fused with c3-c7 with globus.Date of the original implant was on (b)(6) 2015.There was no surgical delay.The procedure successfully completed.Patient status is unknown.Concomitant device: 3.0 ti cervical spine locking screw 14mm (part 04.617.814, lot unknown, quantity 3), zero profile lordotic implant sterile (part 04.617.127s, lot unknown, quantity 1).This report is for a cervical spine locking screw.This is report 1 of 1 for (b)(4).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM
• 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: 8611858
• Report Number: 2939274-2019-58036
• Device Sequence Number: 19361686
• Product Code: OVE
• UDI-Device Identifier: 10705034742274
• UDI-Public: (01)10705034742274
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 04.617.814
• Device Catalogue Number: 04.617.814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/15/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERVICAL SPINE LOCKING SCREW; ZERO-P IMPLANT 7MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 100