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 Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: mni, mnh, kwp and kwq.Implant date was an unknown date in (b)(6) 2017.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.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 available, 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
It was reported that on (b)(6) 2019, the patient underwent a revision of a t10-ilium of the posterior spinal fusion due to a broken right rod between l5 and s1.The patient also has a fracture at t9.New uss screws were placed t6, t7, t8, new rods were contoured and connected it to the uss screws.The new construct was t6-ilium.The original date of the implant was in (b)(6) 2017.It is unknown if there was a surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device: unknown screws (part # unknown, lot # unknown, quantity unknown).This is report 1 of 1 for (b)(4).
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.
Event or Problem Description
Updated concomitant devices: rod (part unknown, lot unknown, quantity 1); uss screws (part unknown, lot unknown, quantity unknown).

• 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: 8667828
• Report Number: 2939274-2019-58446
• Device Sequence Number: 16702571
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 04.600.016
• Device Catalogue Number: 04.600.016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS: USS; UNK - SCREWS; UNK ¿ SCREWS: USS; UNK - SCREWS
• Outcome Attributed to Adverse Event: Required Intervention