MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179771555
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: as described in (b)(4), the patient underwent the 1st revision procedure on (b)(6) 2021, with both the connector and the setscrew in question which were deployed.On an unknown date, it was found that the setscrew had been loose.On (b)(6), the patient was scheduled to undergo another revision procedure for the setscrew replacement.The surgeon commented that the setscrew in question was tightened for sure in the 1st revision procedure.This (b)(4) and (b)(4) are related as follows: 1.(b)(4): about the loose setscrew which was deployed in the 1st revision procedure on (b)(6) 2021.2.(b)(4): about the rod breakage after the primary procedure.This report is for one (1) expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 3 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Additional procode: mnh, kwp, kwq, osh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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: as described in (b)(4), the patient underwent the 1st revision procedure on (b)(6) 2021, with both the connector and the setscrew in question which were deployed.On an unknown date, it was found that the setscrew had been loose.On (b)(6), the patient was scheduled to undergo another revision procedure for the setscrew replacement.The surgeon commented that the setscrew in question was tightened for sure in the 1st revision procedure.This (b)(4) and (b)(4) are related as follows: 1.(b)(4): about the loose setscrew which was deployed in the 1st revision procedure on (b)(6) 2021.2.(b)(4): about the rod breakage after the primary procedure.This report is for one (1) expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 3 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Additional procode: mnh, kwp, kwq, osh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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: d4: lot d9 h3, h4, h6: a review of the receiving inspection (ri) for conn o/o sd top ntch 5.5x5.5 t was conducted identifying that lot number nw260469 was released in a single batch.Batch 1: lot qty of (b)(4) units were released on 29 sep 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned conn o/o sd top ntch 5.5x5.5 t determined no product issues with the device.Signs of use were observed which would not contribute to the complaint condition.No post operative radiographic images were provided.The dimensional inspection was performed and the device met specifications.No issues were observed with the conn o/o sd top ntch 5.5x5.5 t.A complete functional test could not be performed as the mating rod in question was not returned for evaluation.However, a partial functional test determined the connector to assemble with the set screw as expected.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the conn o/o sd top ntch 5.5x5.5 t as no issues were observed with the device and no post operative images/radiographs were provided.A definitive root cause could not be determined for the reported complaint condition from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? the following drawings reflecting the current and manufactured revisions were reviewed: expedium adult, revision connector 5.5 embedded top notch body, ti dimensional inspection: minor dia.Set screw slot= conforming.Device used: caliper.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: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM
• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13505663
• Report Number: 1526439-2022-00197
• Device Sequence Number: 11772108
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: 10705034077819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW260469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SINGLE-INNER SETSCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown