MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731745
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Purulent Discharge (1812); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a removal procedure due to severe pus in the lesion.During the removal procedure the setscrew chipped.The surgeon removed two fragments from the patient¿s lesion.No more fragments were left in the patient.The procedure was completed without surgical delay.The patient received the implants on (b)(6) 2015 and the bone fusion had not been attained at the time of the removal surgery.This report involves one (1) viper system cortical fix polyaxial screw 5.5 7 x 45mm.This is report 5 of 5 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional device product codes: (b)(4).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.
Additional Manufacturer Narrative
Additional narrative: additional device product codes: mni, kwp, kwq, mnh.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a removal procedure due to severe pus in the lesion.During the removal procedure the setscrew chipped.The surgeon removed two fragments from the patient¿s lesion.No more fragments were left in the patient.The procedure was completed without surgical delay.The patient received the implants on (b)(6) 2015 and the bone fusion had not been attained at the time of the removal surgery.This report involves one (1) viper system cortical fix polyaxial screw 5.5 7 x 45mm.This is report 5 of 5 for (b)(4).

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13543489
• Report Number: 1526439-2022-00227
• Device Sequence Number: 3868280
• Product Code: NKB
• UDI-Device Identifier: 10705034352015
• UDI-Public: (01)10705034352015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 7X40MM.; SINGLE-INNER SETSCREW.; UNK - RODS: EXPEDIUM.; VIPER TI SAI POLY 9X80MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown