MAUDE Adverse Event Report: STRYKER SPINE-US 7.0X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482617050

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/04/2019

Event Type  Injury  

Event Description

It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.

Event Description

It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.

Manufacturer Narrative

Visual inspection: the returned screw was inspected and no damage or deformation was observed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Dimensional inspection: not performed because there is no indication the event was related to dimensions of the device.Materials analysis: not performed because there is no indication the event was related to materials properties.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed via x-ray that a screw main body migrated post-operatively.Based on the information received, it was difficult to confirm the number of screws reported to have migrated; conservatively, we deem all reported screws under this event migrated.The root cause for screw migration is due to the unstable construct of the supplemental fixation system secondary to the blocker migration.

• Brand Name: 7.0X50 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8467183
• MDR Text Key: 140422049
• Report Number: 3005525032-2019-00024
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351507
• UDI-Public: 07613327351507
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482617050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention