MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 9 X 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712999
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp, mni, mnh, kwq.Reporter is a synthes employee.A review of the receiving inspection (ri) for exp ti poly screw 9mmx100mm was conducted identifying that lot number rl263029 was released in a single batch.Batch1: lot qty of (b)(4) units were released on october 31, 2017 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.Visual inspection: the exp ti poly screw 9mmx100mm (part# 179712999, lot# rl263029 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were found with the device.The radiograph provided, was evaluated and the set screw was found to have loosened and migrated from the expedium poly screw postoperatively.The complaint condition is hence confirmed.Functional test: a complete functional test could not be performed as the mating rods were not returned along with the devices.A partial functional test was performed on the returned devices and they functioned as intended.Can the complaint be replicated with the returned device(s)? unable to perform dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to the design of the device.Document/specification review: the following drawing(s) was reviewed: exp non-cannulated poly screw, 8-12mm dia x 30-150mm long, ti: current and manufactured revisions.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the exp ti poly screw 9mmx100mm (part# 179712999, lot# rl263029 qty# 1).A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.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) 2021, a patient was scheduled for a planned revisions for a loosened ilium screw.This report involves one (1) expedium spine system polyaxial screw 5.5 x 9 x 100mm.This is report 2 of 2 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 9 X 100MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 12861228
• Report Number: 1526439-2021-02459
• Device Sequence Number: 17279822
• Product Code: NKB
• UDI-Device Identifier: 10705034068350
• UDI-Public: (01)10705034068350
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101993
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 179712999
• Device Catalogue Number: 179712999
• Device Lot Number: RL263029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2017
• 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; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown