MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199723650S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
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 the surgeon performed a single level fusion at l5s1 6 months previously using expedium verse advanced implants.At the 6 month follow up the surgeon took x rays and noted both the tips of the 6.0 x 50 mm s1 screws had broken.The patient is now experiencing back pain and we are looking to revise the case in the future.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X50
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8534171
• Report Number: 1526439-2019-51551
• Device Sequence Number: 13860272
• Product Code: NKB
• UDI-Device Identifier: 10705034443522
• UDI-Public: (01)10705034443522
• Combination Product (Y/N): N
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 199723650S
• Device Catalogue Number: 199723650S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/20/2019
• Supplement Report FDA Received Date: 04/20/2019
• 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