MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CURVED ROD 80MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	498.137
Medical Device Problem Codes	Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: kwp, mni, nkg.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported on (b)(6) 2020, one (1) 4.0mm ti curved rod and one (1) 3.5mm ti curved rod was broken during reverse logistics audit of returned devices.There was no patient involvement and no additional information is available.This report involves one (1) 3.5mm ti curved rod 80mm.This is report 2 of 2 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.Additional information was received indicating the devices were actually remnants of implants which were cut during the surgery and not broken as originally reported.

• Brand Name: 3.5MM TI CURVED ROD 80MM
• 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: 11112066
• Report Number: 2939274-2021-00017
• Device Sequence Number: 19757659
• Product Code: MNH
• UDI-Device Identifier: 10705034788982
• UDI-Public: (01)10705034788982
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.137
• Device Catalogue Number: 498.137
• Device Lot Number: 3404947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/29/2021
• Patient Sequence Number: 1