MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screw: uss/unknown lot.Part and lot number are unknown; udi number is unknown.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.(b)(4).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) 2020, during an unknown procedure, when the surgeon attempted to complete the final tightening of the nut, the screw would not tighten which caused the poly head not to fix as intended.No further information provided.Concomitant devices reported: unknown sleeve (part# unknown, lot# unknown, quantity 1).Unknown rod (part# unknown, lot# unknown, quantity 1).Unknown insertion instrument (part# unknown, lot# unknown, quantity 1).This report is for one (1) unknown mono/polyaxial screws: uss.This is report 2 of 3 for (b)(4).

Event Description

Concomitant devices reported: unknown sleeve (part# unknown, lot# unknown, quantity 1), unknown rod (part# unknown, lot# unknown, quantity 1), unknown insertion instrument (part# unknown, lot# unknown, quantity 1).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10838812
• MDR Text Key: 216396042
• Report Number: 8030965-2020-08931
• Device Sequence Number: 1
• Product Code: MNH
• 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,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: 12/15/2020
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS; UNK - MONO/POLYSCREWCOLLARS/SLEEVES/HEADS: USS; UNK - RODS: USS
• Patient Outcome(s): Required Intervention