MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 7X70; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727770
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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) 2019, during an unknown procedure, the cortical fix fenestrated screw mis ti cfx fen poly 8x80 was being inserted into the s2-alar position and became tight.At the point of no possible further forward momentum, the decision was taken to remove the screw and utilize a smaller diameter screw.The screw came detached from the screw insertion instrument (286725300) as the torque required was too large.Many alternative instruments were used to try and remove the screw with counterclockwise rotations however they didn¿t work.During this screw removal attempt, a screw mis ti cfx fen poly 7x70 placed intradiscally though s1-l5 was to be reversed slightly in order to gain further room and leverage on mis ti cfx fen poly 8x80.At the first attempt to reverse this screw, the polyaxial head eventually pulled over the head of the shank of the screw which had fatigued and broken.There was significant proudness of the screw shank and therefore there was significant time taken to try to remove this.Eventually, several burrs were used to ¿cut through¿ the screw and get it flush to the patients bone where it was left in situ.There was a surgical delay on an unknown number of minutes.Procedure and patient outcome were unknown.This complaint involves two (2) devices.

• Brand Name: MIS TI CFX FEN POLY 7X70
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8688834
• Report Number: 1526439-2019-51745
• Device Sequence Number: 16724314
• Product Code: PML
• UDI-Device Identifier: 10705034282725
• UDI-Public: (01)10705034282725
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 186727770
• Device Catalogue Number: 186727770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other