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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL, PRODUCT CODE: KWP, PRODUCT CODE: KWP
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9738473
• Report Number: 3006460162-2020-00015
• Device Sequence Number: 2483251
• Product Code: KWP
• UDI-Device Identifier: 00841132100103
• UDI-Public: (01)00841132100103(10)M59113-B
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 120