MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI PRECONTOURED ROD 65MM STRAIGHT LENGTH/400MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.600.016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of event is unknown.Additional procodes: mni, mnh, kwp, kwq.Lot number is unknown.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 had a t10-ilium posterior spinal fusion with synthes universal spinal system (uss) on (b)(6) 2017.On an unknown postoperative date, the patient broke the left rod just caudal to the s1 screw.The right rod was intact.The patient also developed proximal junctional kyphosis above the top of the construct.The surgeon performed revision surgery on (b)(6) 2018, and removed both rods.The surgeon then placed new uss screws above the previous fusion at t7, t8, and t9 to address and correct the patient's kyphosis.The surgeon then contoured new rods and connected them from t7-ilium.The procedure was successfully completed.Patient outcome is unknown.Concomitant devices: uss screws, part: unknown, lot: unknown, quantity: unknown; titanium collar, part: 498.010, lot: unknown, quantity: 2; titanium nut 11mm width across flats, part: 498.003, lot: unknown, quantity: 2; rod, part: unknown, lot: unknown, quantity: 1.This report is for a 6.0mm titanium (ti) precontoured rod 65mm straight length/400mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM TI PRECONTOURED ROD 65MM STRAIGHT LENGTH/400MM
• 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: 7890549
• Report Number: 2939274-2018-53849
• Device Sequence Number: 16629295
• Product Code: NKB
• UDI-Device Identifier: 10705034734125
• UDI-Public: (01)10705034734125
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 04.600.016
• Device Catalogue Number: 04.600.016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/19/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR