MAUDE Adverse Event Report: SPINEWAY SA TWIN PEAKS; HOLDER FOR LUMBAR CAGE

Model Number	026HLC1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A new version of the cage holder 026hlc1 was released before the new versions the associated impactors 318hlp1 and 378hls1 were released.The designs of the new cage holder 026hlc1 is not compatible with the previous design of the impactors.If this instrument has reached the surgery room, it would have not been possible to implant the lumbar cage.In that case, an intervention would have been required to prevent permanent damage (absence of disc).

• Brand Name: TWIN PEAKS
• Common Device Name: HOLDER FOR LUMBAR CAGE
• Manufacturer (Section D): SPINEWAY SA; 7 allée du moulin berger; ecully, 69130 ; FR 69130
• Manufacturer Contact: héloïse macaire ; 7 allée du moulin berger; ecully, 69130 ; FR 69130
• MDR Report Key: 13576118
• Report Number: 3010758686-2022-00001
• Device Sequence Number: 11424751
• Product Code: LXH
• UDI-Device Identifier: 03663422600387
• UDI-Public: 3663422600387
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K152355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: 026HLC1
• Device Catalogue Number: 026HLC1
• Device Lot Number: 4210074
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown