MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN TORQUE DEVICES

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon reported to sales rep that he had to revise a patient after two years as an expedium verse screw slipped on a rod in cranial direction.Caudal an innie loosened out of the screw, although all was tightened with help of a torque.The problem is not the implants, but the screwdriver.After tightening with the torque, you can turn about 1/4 turn with the normal screwdriver.The problem is known to you, however, in the context of compression and distraction repeatedly screws slipped after tightening with the torque within verse system.I have already reported this several times within trial-surgery's and it is one of the reasons why i decided against the verse system." concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.

Manufacturer Narrative

Product complaint #: (b)(4).

• Brand Name: UNKNOWN TORQUE DEVICES
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8920384
• MDR Text Key: 155962891
• Report Number: 1526439-2019-52015
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR