MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE SET SCREW, LARGE; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted.The investigation is completed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.

Event Description

It has been reported that following the placement of a spinal construct system, a distal set screw was noted to be loose.Patient underwent revision surgery on (b)(6) 2019 to remove set screw and corresponding pedicle screw.During the revision surgery, the surgeon identified a fractured pedicle screw.

Manufacturer Narrative

Reference: (b)(4).This follow-up report is being submitted to relay additional information.D11 updated.Concomittant devices reported by customer: item: 00-1003-4001 lot: m93500-b udi: (b)(4), description: set screw, large.Item: 00-1003-4001 lot: m93499-b udi: (b)(4), description: set screw, large.Item: 00-1003-4001 lot: m93498-b udi: (b)(4), description: set screw, large.Item: 00-1003-4001 lot: unknown udi: unknown, description: set screw, large.Item: 00-1300-0655 lot:041820-e udi: (b)(4), description: 5.5/6.0 polyaxial pedicle screw 6.0mm x 55mm.Item: 00-1300-0655 lot: unknown udi: unknown, description: 5.5/6.0 polyaxial pedicle screw 6.0mm x 55mm.H6: result code updated to 3207 - 3252.H6 method code updated to 3331.X-rays were reviewed and complaint was confirmed.Dhr was reviewed and results were inconclusive.Root cause was unable to be determined.

• Brand Name: RESPONSE SET SCREW, LARGE
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9689063
• MDR Text Key: 185754948
• Report Number: 3006460162-2019-00064
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1003-4001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 17 YR