MAUDE Adverse Event Report: DEPUY SPINE INC MIS CANN POLY SCW 6X40MM,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186715640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp;kwq; mnh;mni;osh.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 product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient had suffered from adjacent centrum disorder.The patient scheduled to undergo a plif revision procedure (l4/5).The primary plif(5/s) was performed on (b)(6) 2012.No further information is available.This complaint involves four (4) devices.This report is for one (1) mis cann poly scw 6x40mm,ti.This is report 3 of 4 for complaint (b)(4).

• Brand Name: MIS CANN POLY SCW 6X40MM,TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12661105
• Report Number: 1526439-2021-02208
• Device Sequence Number: 7083922
• Product Code: NKB
• UDI-Device Identifier: 10705034122342
• UDI-Public: 10705034122342
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186715640
• Device Catalogue Number: 186715640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS CANN POLY SCW 6X40MM,TI; MIS CANN POLY SCW 6X40MM,TI; MIS CANN POLY SCW 6X40MM,TI
• Outcome Attributed to Adverse Event: Required Intervention