MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 SPINE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL, PRODUCT CODE: KWP, PRODUCT CODE: KWP

Model Number 00-1003-4001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Catalog # 00-1003-4001, lot #m59113-b, quantity of fifteen (15).Complaint sample was returned for evaluation.Reported event was confirmed.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00082, 3006460612-2019- 00083, 3006460612-2020-00014.

Event Description

It has been reported that approximately three years following the placement of a response spinal construct, the patient underwent a revision due to rod fracture and loose set screws.No additional patient consequences were reported.

• Brand Name: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL, PRODUCT CODE: KWP, PRODUCT CODE: KWP
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9738473
• MDR Text Key: 190605554
• Report Number: 3006460162-2020-00015
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00841132100103
• UDI-Public: (01)00841132100103(10)M59113-B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1003-4001
• Device Catalogue Number: 00-1003-4001
• Device Lot Number: M59113-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 120