MAUDE Adverse Event Report: APIFIX LTD MID-C XLP 125 MM WITH EXTENSION OF 40 MM; POSTERIOR RATCHETING ROD SYSTEM,

Model Number MID-C XLP 125 MM WITH EXTENSION OF 40 MM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

A review of dhr has demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.A review of the patient's x-rays demonstrates implant breakage.Along the time from implantation to the 2 years follow-up, the patient's kyphosis significantly increased (from 49° at pre-op to around 70° at the last follow up).The increase in kyphosis angle most likely pushed against the center of the implant causing it to break.Chen et al., [1] demonstrated in their study comparing treatment in eos patients with and without hyperkyphosis that the most common implant-related and alignment related complication in the eos hyperkyphotic population was rod fracture [1] chen z, qiu y, zhu z, li s.How does hyperkyphotic early-onset scoliosis respond to growing rod treatment, 2016;00:1-6.

Event Description

Patient was operated as part of clinical study af-mid-c-eos 01-16 (protocol number dms 1356 rev d, screening # 053-0001) on (b)(6) 2018, with internal apifix number 002.On (b)(6) 2020, the surgeon reported by e-mail that the 2 year fu x-ray showed a breakage of the mid-c xlp implant at the base.Also, the surgeon reported that the patient complained of light pain located at the thoracic hub for the last 2-3 months.No injury has occurred and during the clinical examination, the patient was free of any pain.The clinical appearance did not indicate anything.

• Brand Name: MID-C XLP 125 MM WITH EXTENSION OF 40 MM
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM,
• Manufacturer (Section D): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer (Section G): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer Contact: adi prager ; 17 tehelet street; misgav business park; misgav, 20174-00 ; IS 2017400
• MDR Report Key: 10216756
• MDR Text Key: 198106174
• Report Number: 3013461531-2020-00003
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993792
• UDI-Public: 7290014993792
• Combination Product (y/n): N
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 06/28/2020

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?: No
• Device Operator: No Information
• Device Expiration Date: 09/07/2021
• Device Model Number: MID-C XLP 125 MM WITH EXTENSION OF 40 MM
• Device Catalogue Number: AF125 EOS
• Device Lot Number: AF 09-01-16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR