MAUDE Adverse Event Report: PEGA MEDICAL INC. THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM; COMPRESSION SCREW, Ø2.7X32MM

Model Number	COMPRESSION SCREW, Ø2.7X32MM
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nonunion of the bone occurred most likely due to the osteopenic condition of the patient's bone.It appears that the cyclic loading after the nonunion resulted in the unscrewing of the connector and the failure of the most distal cortical screw.Both consequences are predictable considering the long period of implantation with the nonunion (more than 2 years).
Event or Problem Description
A compression screws attaching the plate to the bone broke being implanted in an infant patient.Initial surgery: (b)(6) 2018 (b)(6)of age).2 years and 3 months implantation before detection of failure.

• Brand Name: THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM
• Common Device Name: COMPRESSION SCREW, Ø2.7X32MM
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• MDR Report Key: 10693246
• Report Number: 3000327445-2020-00006
• Device Sequence Number: 2954018
• Product Code: KTT
• UDI-Device Identifier: 07540194005854
• UDI-Public: (01)07540194005854
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: COMPRESSION SCREW, Ø2.7X32MM
• Device Catalogue Number: POP-OB27-32
• Device Lot Number: 160714-020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/16/2020
• 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: 4 YR
• Patient Weight: 18