MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 6MM X 50MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	179788650
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp, mni, osh, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image provided shows loose screws.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 unknown date, there was a post-operative disconnection with a failure at screw, rod interface at distal end of scoliosis correcting segmental pedical screw construct.The surgeon suspects that a certain amount of medial or lateral force from the rod on the tulip head splays head enough to allow slippage.There is no apparent malfunction with the rod.The patient is currently characterized as an asymptomatic hardware failure.No further information provided.Concomitant device reported: rod (part# unknown, lot# unknown, quantity 2); single-inner setscrew (part # 179702000, lot # unknown, quantity 1); screw (part # unknown, lot # unknown, quantity 4).This report is for one (1) exp ti uni screw 6mm x 50mm.This is report 1 of 2 for (b)(4).

• Brand Name: EXP TI UNI SCREW 6MM X 50MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10567796
• Report Number: 1526439-2020-01769
• Device Sequence Number: 16935865
• Product Code: MNH
• UDI-Device Identifier: 10705034081410
• UDI-Public: (01)10705034081410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 179788650
• Device Catalogue Number: 179788650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 67