MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI CSLP VARIABLE ANGLE 4 LEVEL/80MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	450.186
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Patent identifier: (b)(6).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 product was received; no conclusion could be drawn at the time of filing this report.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) 2021, patient underwent an unknown surgical procedure for spinal fusion.Cslp va plate locking ring came dislodged.The procedure was completed successfully with a surgical delay of 30 minutes.Patient outcome is unknown.This complaint involves two (2) devices.This report is for (1) ti cslp variable angle 4 level/80mm.This report is 2 of 2 for (b)(4).

• Brand Name: TI CSLP VARIABLE ANGLE 4 LEVEL/80MM
• 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: 12216684
• Report Number: 2939274-2021-04240
• Device Sequence Number: 4495092
• Product Code: KWQ
• UDI-Device Identifier: 10705034781051
• UDI-Public: (01)10705034781051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 450.186
• Device Catalogue Number: 450.186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI CSLP VARIABLE ANGLE 4 LEVEL/80MM
• Patient Age: 78 YR