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).The device was received, the investigation is in progress, 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 (2) devices.This report is for (1) ti cslp variable angle 4 level/80mm.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part # 450.186, synthes lot # 4212229, supplier lot # na, release to warehouse date: 22 jan 2001, manufactured by synthes brandywine, no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the ti cslp variable angle 4 level/80mm (p/n: 450.186, lot #: 4212229) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was missing the bushing (es0120) component in one of the holes.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing component, so the dimensional inspection was not performed.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Ti cervical spine locking plate variable angle, 4 level: current) and manufactured.Complaint confirmed? yes.Investigation conclusion: the complaint condition was confirmed for the ti cslp variable angle 4 level/80mm (p/n: 450.186, lot #: 4212229).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The component was likely misplaced during the device's handling.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• 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: 12215015
• Report Number: 2939274-2021-04239
• Device Sequence Number: 14576554
• Product Code: KWQ
• UDI-Device Identifier: 10705034781051
• UDI-Public: (01)10705034781051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031276
• 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,Followup
• 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
• Device Lot Number: 4212229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI CSLP VARIABLE ANGLE 4 LEVEL/80MM; TI CSLP VARIABLE ANGLE 4 LEVEL/80MM
• Patient Age: 78 YR