MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723640
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 a set screw was washed out of the wound on (b)(6) 2020 for an infection.The set screw was placed back on and then final tightening was completed.The primary surgery was for a l4/l5 posterior lumbar interbody fusion (plif) on (b)(6) 2020.Concomitant device reported: torque wrench handle 80in-lb (part#: 299704320, lot#: unknown, quantity 2).Verse x25 inserter/tightener (part#: 299704230, lot#: unknown, quantity 4).This is report 2 of 4 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10211424
• Report Number: 1526439-2020-01277
• Device Sequence Number: 11289756
• Product Code: MNI
• UDI-Device Identifier: 10705034403090
• UDI-Public: (01)10705034403090
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 199723640
• Device Catalogue Number: 199723640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention