MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro-code: kwp, mnh, mni.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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 a posterior cervical c2-c6 w c2 translaminar screws procedure.During the procedure, while the surgeon was inserting a titanium cancellous polyaxial screw the screw broke where the screw head meets the shank.The screw was removed and discarded and another of the same screw size was used.The procedure was successfully completed with no surgical delay.There was no adverse consequence to the patient.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8907513
• Report Number: 2939274-2019-59908
• Device Sequence Number: 14087853
• Product Code: NKG
• UDI-Device Identifier: 10705034738888
• UDI-Public: (01)10705034738888
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• 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): 07/22/2019

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: 04.614.234
• Device Catalogue Number: 04.614.234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/19/2019
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 129