MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X90MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179704990
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional device product codes: kwp; mni; mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the patient underwent the primary procedure and the viper polyaxial screw was implanted at s2.On an unknown postoperative date it was found that the screw had been loose.The patient underwent a revision procedure for loose screw replacement on (b)(6) 2022.No further information is available.This incident is related to (b)(4) which captures the intraoperative screwdrivers breakages during the revision procedure.This report is for one (1) viper ti sai poly 9x90mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: VIPER TI SAI POLY 9X90MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13668368
• Report Number: 1526439-2022-00337
• Device Sequence Number: 4995879
• Product Code: NKB
• UDI-Device Identifier: 10705034265865
• UDI-Public: (01)10705034265865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 179704990
• Device Catalogue Number: 179704990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown