MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI SOFT ROD 500MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.158
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Additional pro-codes: mni, kwp, kwq, nkb.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.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.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
Libertas: it was reported on (b)(6) 2019, the 6.0mm titanium soft rod 500mm was broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 6.0MM TI SOFT ROD 500MM
• 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: 9263630
• Report Number: 2939274-2019-61889
• Device Sequence Number: 1879064
• Product Code: MNH
• UDI-Device Identifier: 10705034789095
• UDI-Public: (01)10705034789095
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 498.158
• Device Catalogue Number: 498.158
• Device Lot Number: 4141047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1