MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X45; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723645
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Foreign Body In Patient (2687)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: mni.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number reported as (b)(6).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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a l4-s1 plif was extended to l3-s1 due to adjacent segment disease.Upon extension, it was discovered that the left s1 screw was broken.The shaft was left in situ and the head removed.A new left s1 screw was placed next to the old screw shaft.The initial procedure took place on (b)(6) 2019.The procedure was successfully completed.There was a surgical delay of ten (10) minutes.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown set screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 5.5 exp verse fen scr 6.0x45.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported a revision procedure occurred on an unknown; the explanted devices are not available to be returned to the manufacturer.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, d6, h6.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.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X45
• 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: 10831636
• Report Number: 1526439-2020-02169
• Device Sequence Number: 2960395
• Product Code: PML
• UDI-Device Identifier: 10705034403083
• UDI-Public: (01)10705034403083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 199723645
• Device Catalogue Number: 199723645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.