MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MOSS MIAMI 5.5 OUTER NUT, TI; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	175527000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional product code: kwq; mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on an unknown date that, the patient was scheduled for a plif revision surgery (extension up to l3-4 with expedium system) on (b)(6) 2021.Originally, the patient underwent for primary plif procedure between l4-5 on (b)(6) 2003.The moss-miami implants in question need to be replaced with expedium implants in the revision procedure.No further information is available.This complaint involves six (6) devices.This report is for (1) moss miami 5.5 outer nut, ti.This report is 13 of 14 for (b)(4).

• Brand Name: MOSS MIAMI 5.5 OUTER NUT, TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12214006
• Report Number: 1526439-2021-01477
• Device Sequence Number: 11558471
• Product Code: KWP
• UDI-Device Identifier: 10705034033495
• UDI-Public: 10705034033495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 175527000
• Device Catalogue Number: 175527000
• Device Lot Number: 000AT389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention