MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM; MANDIBLE DISTRACTION DEVICES

Model Number	04.315.744.01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent a revision procedure to re-position the cmf-distractor for bone screw loosening in the posterior footplate.During the revision procedure the original implants which consist of one (1) 1.0mm mesh foot b-type, one (1) 1.0mm mesh foot c-type, 15mm bc distractor, one (1) 30mm removal extension arms and seven (7) 1.3mm titanium raised head screws were all explanted and a new implant was implanted and needed to be repositioned due to the challenging bony anatomy of the patient.No x-rays were involved in this procedure.The patient is a neonate and as the patient was undergoing distraction post operatively the surgeon believed he could get better results by adjusting the position on the distractor.The procedure was successfully completed without any surgical delay.Patient status is unknown.Concomitant device reported: 1.0mm mesh foot b-type for cmf distractor (part # 04.315.202, lot # unknown, quantity 1), 1.0mm mesh foot c-type for cmf distractor (part # 04.315.203, lot # unknown, quantity 1), bc distractor body end act.(part # 04.315.023, lot # unknown, quantity 1), removable extension arm-flex (part # 04.315.125, lot # unknown, quantity 1).This complaint involves seven devices (7) devices.This report is for one (1) 1.3mm ti raised head screw self-drilling/plusdrive®/4mm.This report is 6 of 7 for (b)(4).

• Brand Name: 1.3MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM
• Common Device Name: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10036489
• Report Number: 2939274-2020-02288
• Device Sequence Number: 3053191
• Product Code: MQN
• UDI-Device Identifier: 10887587072180
• UDI-Public: (01)10887587072180
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: 04.315.744.01
• Device Catalogue Number: 04.315.744.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 DA
• Patient Weight: 5