MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is unknown in 2020.Additional product code: mnh mni kwq kwp.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 unknown date during an unknown procedure, the matrix polyaxial screw detached from an unknown matrix polyaxial head during insertion.The surgeon was using a matrix pre assembled screws in which the shaft and the head of the screw were attached.The surgeon attempted to attach another polyaxial head and it would not attach.The surgeon also noticed that their may have been an issue with the screw shaft head.The matrix polyaxial screw was explanted and a new screw was used.There was surgical delay of three (3) minutes.The procedure was completed successfully.There was no patient consequence reported.This complaint involves three (3) devices.This is report 2 of 3 for (b)(4).
Event or Problem Description
Concomitant devices reported: 7.0mm ti matrix polyaxial screw 40mm thread length (part # 04.632.740, lot # unknown, quantity 1); mono/polyaxial head (part # unknown, lot # unknown, quantity 1).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B5: added concomitant device.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.
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.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 MATRIX TOP LOADING POLYAXIAL HEAD
• 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: 9924217
• Report Number: 2939274-2020-01719
• Device Sequence Number: 3329565
• Product Code: NKB
• UDI-Device Identifier: 10705034744971
• UDI-Public: (01)10705034744971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2020

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: 04.632.001
• Device Catalogue Number: 04.632.001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 06/16/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/30/2020; 06/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.0MM TI MTRX PLYXL SCW 40MM THRD LNTH; UNK - MNO/PLXAL SCW CLRS/SLVS/HDS: MTRX
• Patient Age: 47 MO