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

Model Number	04.632.645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: mnh, mni, kwq, kwp.Complainant part is not expected to be returned for manufacturer review/ investigation.(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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent a revision surgery due to a concord lift implant collapsing.It was noted that two (2) matrix polyaxial screws were also broken and thought to be caused by the collapsing cage.All four (4) of the previous matrix screws were removed and replaced with four (4) matrix screw 7 x 45.The primary cause of the need for revision surgery was due to the concord lift collapsing.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: matrix polyaxial screws (part # 04.632.645, lot # unknown, qty 3); locking caps (part # unknown lot # unknown, qty 4), rod (part # unknown, lot # unknown, qty 2), concord lift (part # 197809023l, lot # unknown, quantity 1).This is report 1 of 2 for complaint (b)(4).

• Brand Name: 6.0MM TI MATRIX POLYAXIAL 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: 9795321
• Report Number: 2939274-2020-01153
• Device Sequence Number: 2574745
• Product Code: NKB
• UDI-Device Identifier: 10705034745534
• UDI-Public: (01)10705034745534
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.632.645
• Device Catalogue Number: 04.632.645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention