MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 500MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes mni, kwp, kwq, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 the patient underwent revision surgery on (b)(6) 2018 due to bilaterally broken rods of synthes universal spinal system (uss) at thoracic 10.The patient initially had a t2-ilium posterior spinal fusion on an unknown date.For revision surgery, the surgeon bilaterally cut the existing rods above and below the break at t10, and cut two new 300mm rods.The surgeon then connected the new rods to the existing cranial and caudal segments of the rods already implanted along with the existing screws.The procedure was successfully completed.It is unknown if there was a surgical delay.Patient outcome is unknown.This report is for one (1) 6.0mm ti hard rod 500mm.This is report 1 of 2 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 500MM
• Common Device Name: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7933955
• Report Number: 2939274-2018-54150
• Device Sequence Number: 1484857
• Product Code: MNH
• UDI-Device Identifier: 10705034788944
• UDI-Public: (01)10705034788944
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992739
• 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
• Report Date (Section B): 09/13/2018

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: 498.119
• Device Catalogue Number: 498.119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR