MAUDE Adverse Event Report: DEPUY SPINE INC VIPER UNI SCREW 5X35MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186720535

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

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.Reporter is a j&j representative.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.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, while doing the final lock, after the derogation maneuver, the surgeon found that the rod was not tightly blocked into the uniplanar screw heads.This in comparison with the upper and lower poly axial screws with the fixation to the rod was very solid.With the uniplanar screws, one could clearly see an unexpected medio-lateral movement / degree of freedom despite an ad-hoc tightening with the torque handle.Procedure was completed successfully without any surgical delay.Concomitant device reported: unknown torque device (part # unknown, lot # unknown, quantity unknown).This complaint involves four (4) devices.This report is for (1) viper uni screw 5x35mm ti.This report is 4 of 4 for (b)(4).

• Brand Name: VIPER UNI SCREW 5X35MM TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 13014237
• MDR Text Key: 284130947
• Report Number: 1526439-2021-02564
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034125619
• UDI-Public: 10705034125619
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186720535
• Device Catalogue Number: 186720535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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: UNKNOWN TORQUE DEVICES; VIPER UNI SCREW 5X35MM TI; VIPER UNI SCREW 5X35MM TI; VIPER2 STRAIGHT ROD300MM, COCR