MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR; CRANIAL DISTRACTION SYSTEM

Model Number	04.315.125
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: mqn.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j employee.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 flexible extension arm would not disengage from cmf distractor body during distraction osteogenesis removal of extension arms after completion of activation phase.The surgeon took the patient back into the operating room to remove the extension arm only.It is unknown if there was a surgical delay reported.The procedure and patient outcomes were unknown.This report is for one (1) removable extension arm-flex 30mm for cmf distractor.This is report 3 of 3 for (b)(4).

• Brand Name: REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR
• Common Device Name: CRANIAL DISTRACTION SYSTEM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10864284
• Report Number: 2939274-2020-05220
• Device Sequence Number: 16803162
• Product Code: PBJ
• UDI-Device Identifier: 10887587015668
• UDI-Public: (01)10887587015668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: 04.315.125
• Device Catalogue Number: 04.315.125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention