MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 50MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	498.102
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the patient underwent a removal surgery for bilateral broken rods on a posterior spinal fusion that was synthes spine uss.The previous surgery date was (b)(6) 2018.Surgeon discovered that rods were broke for an unknown reason at an unknown time.During the revision, the surgeon removed all the synthes uss hardware that was placed at l4-l5.The patient had non union at the l4-l5 level and surgeon placed new synthes uss hardware.Procedure was completed successfully.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 6.0mm ti hard rod 50mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 6.0MM TI HARD ROD 50MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11903249
• Report Number: 2939274-2021-02667
• Device Sequence Number: 19720502
• Product Code: MNH
• UDI-Device Identifier: 10705034788838
• UDI-Public: (01)10705034788838
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 498.102
• Device Catalogue Number: 498.102
• Device Lot Number: 741452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR