MAUDE Adverse Event Report: SYNTHES GMBH UNK - LOCKING/SET SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Compatibility Problem (2960)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021 during a spinal fusion procedure treating myelopathy, the threads of the slip sleeve did not properly engage with the threads of the unknown screw.The procedure was completed using a replacement sleeve.There was no surgical delay.There is no further information available.This report is for one (1) unk - locking/set screws.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

510k: this report is for an unknown locking/set screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

• Brand Name: UNK - LOCKING/SET SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12416160
• MDR Text Key: 280706209
• Report Number: 8030965-2021-07449
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1
• Treatment: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HOLD-SL; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.