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

Device Problem Device Slipped (1584)

Patient Problems Purulent Discharge (1812); Non-union Bone Fracture (2369)

Event Type  Injury  

Event 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).

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.

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 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
• Type of Device: 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
• MDR Text Key: 285693643
• Report Number: 1526439-2022-00227
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034352015
• UDI-Public: (01)10705034352015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X40MM.; SINGLE-INNER SETSCREW.; UNK - RODS: EXPEDIUM.; VIPER TI SAI POLY 9X80MM.
• Patient Outcome(s): Required Intervention