MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.639.645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: mnh, mni, kwq, kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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 lumbar fusion revision surgery to extend the construct 1 level up for adjacent level disease at l4-l5.The construct was s1-l5 and was extended up to l4-s1.Two (2) 6.0mm titanium matrix screw, two (2) 5.5mm titanium curved rod, two (2) titanium matrix locking cap, and two (2) titanium matrix top loading polyaxial head were the devices implanted at l4, the site of the adjacent level disease at l4-l5.Procedure was successfully completed.Patient status is unknown.This report is for a 6.0mm ti matrix screw 45mm thread length.This is report 2 of 8 for (b)(4).

• Brand Name: 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8404911
• Report Number: 2939274-2019-56883
• Device Sequence Number: 2326138
• Product Code: NKB
• UDI-Device Identifier: 10705034749310
• UDI-Public: (01)10705034749310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.639.645
• Device Catalogue Number: 04.639.645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention