MAUDE Adverse Event Report: SYNTHES GMBH ZERO-P IMP 8MM HT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	04.617.128S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 history lot - a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 the during the column arthrodesis surgery, material consigned cage for column fusion reported by the doctor was loose and impossible to use.It was then delivered to cme for disinfection to deliver it to the company.This complaint was received directly from brazilian health authority (anvisa), therefore no further information can be obtained other than what is described.This report is for one (1) zero-p implant 8mm height lordotic-sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: ZERO-P IMP 8MM HT LORDOTIC-STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12549146
• Report Number: 8030965-2021-08137
• Device Sequence Number: 11038134
• Product Code: OVE
• UDI-Device Identifier: 10705034741918
• UDI-Public: (01)10705034741918
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K072981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.617.128S
• Device Catalogue Number: 04.617.128S
• Device Lot Number: 2L32075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1