MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 10CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.010S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id: (b)(6).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.Product was not returned.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 on (b)(6) 2019, during an unknown procedure, a mixed 10cc norian drillable inject had leaked when pushed into cement, thus, was not used for the case.The surgeon used a backup of 5cc.It is unknown if there was surgical delay.No consequence to patient.Concomitant device reported: unknown norian drillable fast set putty (part# /lot# unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) norian drillable inject 10cc-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: NORIAN DRILLABLE INJECT 10CC-STERILE
• Common Device Name: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9136165
• Report Number: 2939274-2019-61056
• Device Sequence Number: 11515082
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Patient Age: 35 YR