MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH M-M 5.5 INNER SCREW, TI; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	175526000
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) m-m 5.5 inner screw, ti.This report is 11 of 14 for (b)(4).

• Brand Name: M-M 5.5 INNER SCREW, 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: 12213998
• Report Number: 1526439-2021-01475
• Device Sequence Number: 16939044
• Product Code: KWP
• UDI-Device Identifier: 10705034033488
• UDI-Public: 10705034033488
• 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: 175526000
• Device Catalogue Number: 175526000
• Device Lot Number: 000AT384
• 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