MAUDE Adverse Event Report: OSTEOMED CRANIOFACIAL RIGID FIXATION SYSTEM 1.2MM SCREW

Catalog Number 204-1210

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, osteomed was notified of a complaint against p/n 204-1210.Per the initial complaint info, the mini screw 1.2mm was broken during removal, after implantation.Per add'l info received on (b)(6) 2014, the screw was being removed to prepare for the implant.In order to remove the broken screw, the physician dug up the bone and filled the void with bone substitute.The pt received his implant on (b)(6) 2014 and is in good condition.

Manufacturer Narrative

Upon initial review of the complaint, the details of the event, as communicated on (b)(6) 2014, did not necessitate an mdr.However, based upon our review of the info received on 10/14/2014, an mdr is required.Therefore, the complaint file has been documented with the mdr decision change and mdr filing.The device has been shipped back to osteomed, but has not been received.Upon receipt, the device will be evaluated.

Manufacturer Narrative

The results of the investigation shows that the screw was implanted past osteogenesis.Per the ifu, the cfx screws are intended for temporary fixation only until osteogenesis occurs.The screw was implanted for a period of nine (9) months before removal.The evaluation of the returned screw suggests that the damage observed was due to removal by bending and torquing of the screw.The review of the device history record did not identify any non-conformances.The review of complaints and ncrs did not identify a similarly related issue within the last year.No further action required.This issue will be monitored through internal trending.Qa note: during an audit of mdr submissions, we identified that the follow up for this report was inadvertently not submitted.

• Brand Name: CRANIOFACIAL RIGID FIXATION SYSTEM 1.2MM SCREW
• Type of Device: 1.2MM SCREW
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer Contact: latoia phillips ; 3885 arapaho road; addison, TX 75001 ; 9726774743
• MDR Report Key: 4231774
• MDR Text Key: 5067447
• Report Number: 2027754-2014-00012
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K911936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

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: Health Professional
• Device Catalogue Number: 204-1210
• Device Lot Number: 1047390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: 09/19/2014
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR