MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9.0MM TI MATRIX POLYAXIAL SCREW 90MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.990
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code mnh mni kwq kwp.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 product was received; 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 that on an unknown date, the 9.0mm titanium matrix polyaxial (spine) screws thread length was not mating with the driver and the screwdriver was unknown.It is unknown if there was a surgical delay.It is unknown if the procedure successfully completed.No patient consequence.This complaint involves two (2) device.This is 1 of 2 for report (b)(4).

• Brand Name: 9.0MM TI MATRIX POLYAXIAL SCREW 90MM THREAD LENGTH
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9802246
• Report Number: 2939274-2020-01181
• Device Sequence Number: 572631
• Product Code: NKB
• UDI-Device Identifier: 10705034746029
• UDI-Public: (01)10705034746029
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• 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): 02/11/2020

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: 04.632.990
• Device Catalogue Number: 04.632.990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Patient Sequence Number: 1