MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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, 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an l3-s1 transforaminal lumbar interbody fusion (tlif) using a matrix with opal cages.The top matrix set screws were loosened/popped off at bilateral l3.The set screws and rods were removed bilaterally and replaced with l3 poly heads bilaterally along with new set screws and rods.They also added a transconnector.Fragments were generated and were removed easily through reinstrumentation.Procedure was successfully completed.Patient status was good.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity unknown); unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

• Brand Name: TI MATRIX LOCKING CAP
• 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: 8588965
• Report Number: 2939274-2019-57891
• Device Sequence Number: 11179374
• Product Code: NKB
• UDI-Device Identifier: 10705034744964
• UDI-Public: (01)10705034744964
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.632.000
• Device Catalogue Number: 04.632.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention