MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX TOP LOADING POLYAXIAL HEAD; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	04.632.001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: kwq, mni, mnh, kwp, nkb.Without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation, device is implanted.(b)(4).Investigation summary : complaint summary: it was reported that on (b)(6) 2021, apparent dislodging observed in post-op films.In reviewing a post-op x-ray, the doctor observed that one of the matrix polyaxial heads may have dislodged from the matrix bone screw at l3.There were no obvious issues with implants or instrumentation intra-operatively and the surgeon followed the surgical technique guidelines to verify the implant placement prior to final tightening.Implants were placed on (b)(6) 2021.Unknown if future revision will be required.This complaint involves two (2) devices.Photo investigation: the device was not returned.A photo-investigation was performed on the x-ray image located in pc attachment ¿(b)(4)".Upon investigating the x-ray provided, one of the matrix screw is found little dislocated from polyaxial screw head.However, the dislocation of the screw head cannot be confirmed based on provided x-ray.The root cause of the dislocated matrix screw from polyaxial screw head cannot be confirmed based on the available x-ray.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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, apparent dislodging observed in post-op films.In reviewing a post-op x-ray, the doctor observed that one of the matrix polyaxial heads may have dislodged from the matrix bone screw at l3.There were no obvious issues with implants or instrumentation intra-operatively and the surgeon followed the surgical technique guidelines to verify the implant placement prior to final tightening.Implants were placed on (b)(6) 2021.Unknown if future revision will be required.This complaint involves two (2) devices.This report is for one (1) ti matrix top loading polyaxial head.This report is 2 of 2 for (b)(4).

• Brand Name: TI MATRIX TOP LOADING POLYAXIAL HEAD
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11881496
• Report Number: 2939274-2021-02576
• Device Sequence Number: 3747039
• Product Code: KWP
• UDI-Device Identifier: 10705034744971
• UDI-Public: (01)10705034744971
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREADM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.632.001
• Device Catalogue Number: 04.632.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH; UNK - LOCKING/SET SCREWS: MATRIX; UNK - RODS: MATRIX
• Outcome Attributed to Adverse Event: Required Intervention