MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 a revision surgery was performed due to prior sepsis.The l4/s1 metalwork, l4/5 transforaminal lumbar interbody fusion (tlif) cage (concorde carbon fiber-reinforced polymer (cfrp)), decompression and re instrumented l3 were removed.The previous l4-s1 screws were removed in the first stage of the operation and the expedium verse screws were implanted at l3 with the tabs.An anterior lumbar interbody fusion (alif) was completed on (b)(6) 2020, followed by completion of posterior instrumentation on (b)(6) 2020.The screw was not explanted on (b)(6) 2020.The surgeon needed to extend the fusion so the screws were inserted during the first stage on (b)(6) 2020 and then the remaining screws were implanted on (b)(6) 2020 and connected the final construct, all tabs were removed at this stage.This report is for one (1) 5.5 exp verse screw 6.0 x 50.This is report 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D5, d6: provided for reporting.H3, h6: investigation summary product was not returned.It was discarded.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 SCREW 6.0 X 50
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9792115
• Report Number: 1526439-2020-00644
• Device Sequence Number: 2574158
• Product Code: NKB
• UDI-Device Identifier: 10705034442266
• UDI-Public: (01)10705034442266
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 199721650
• Device Catalogue Number: 199721650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention