MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CANCELLOUS POLYAXIAL SCREW 18MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	04.614.018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing cervical fusion.This report captures the following complications: mechanical complication internal orthopedic device/implant/graft, nos (1): patient no (b)(6), female, (b)(6) underwent posterior c3-7 decompression, c3-t1 fusion with synapse 3.5 instrument (latex allergy) was readmitted due to mechanical complication internal orthopedic device/implant/graft, nos.This report is for a posterior cervical systems (synapse) locking screw.This is report 1 of 20 for (b)(4).Additional complications for this cer are captured on related complaints (b)(4).
Additional Manufacturer Narrative
Patient no (b)(6).Additional product codes: kwp, mnh, nkg.Initial reporter is a synthes employee.(b)(4).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.

• Brand Name: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 18MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12160786
• Report Number: 2939274-2021-03917
• Device Sequence Number: 14466293
• Product Code: MNI
• UDI-Device Identifier: 10705034738369
• UDI-Public: (01)10705034738369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.614.018
• Device Catalogue Number: 04.614.018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR