MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 125MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.105
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 removal surgery in (b)(6) 2021 (unknown day), the surgeon performed an l3-s1 posterior spinal fusion on the patient for a traumatic l4-l5 fracture-dislocation.At an unknown point in time, the patient broke both rods between l4 and l5.The patient estimates the rods broke at about the 12-week post-op date.On (b)(6) 2021, the surgeon performed the revision to address the broken rods.He removed both the rods.The procedure was successfully completed.No patient consequences are reported.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) 6.0mm ti hard rod 125mm.This report is 1 of 2 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 125MM
• 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: 11931532
• Report Number: 2939274-2021-02754
• Device Sequence Number: 1060194
• Product Code: MNH
• UDI-Device Identifier: 10705034788869
• UDI-Public: 10705034788869
• 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: 2021
• 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): 05/10/2021

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: 498.105
• Device Catalogue Number: 498.105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR