MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM TI SIDE-OPENING SCREW 55MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.755
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
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.(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 (b)(6) 2019 the patient underwent a revision of universal spinal system (uss) due to the left l2 nut and collar coming off of the screw.The patient had a t8-l2 posterior spinal fusion on (b)(6) 2018.The collar appeared to be slightly splayed, however the surgeon did not think this was enough to cause it to come apart.The nut, collar and left l2 screw were removed and replaced with a uss screw of the same size.The surgeon placed a new nut and collar then tightened them.The left l1 screw was tightened as well.The procedure was successfully completed.Concomitant devices: unknown lamina/pedicle/ process hooks: uss (part # unknown, lot # unknown, quantity unknown), unknown locking/ set screws: uss (part # unknown, lot # unknown, quantity unknown), unknown mono/polyaxial screw collars/sleeves/heads: uss (part # unknown, lot#unknown, quantity unknown), unknown mono/polyaxial screws: uss (part # unknown, lot # unknown, quantity unknown), unknown rod uss (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 7.0 mm ti side-opening screw 55 mm.This is report 2 of 3 for (b)(4).
Event or Problem Description
It was reported on (b)(6) 2019, the patient underwent revision of universal spinal system (uss) synthes devices due to an unknown point in time the left l2 nut and collar came off of the screw.
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: 7.0MM TI SIDE-OPENING SCREW 55MM
• 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: 9418000
• Report Number: 2939274-2019-62526
• Device Sequence Number: 1671312
• Product Code: MNH
• UDI-Device Identifier: 10705034791630
• UDI-Public: (01)10705034791630
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 498.755
• Device Catalogue Number: 498.755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS; UNK - LOCKING/SET SCREWS: USS; UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS; UNK - MONO/POLYAXIAL SCREWS: USS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES: USS; UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS; UNK - LOCKING/SET SCREWS: USS; UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS; UNK - MONO/POLYAXIAL SCREWS: USS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES: USS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 184