MAUDE Adverse Event Report: TEDAN SURGICAL INNOVATIONS, INC ALIF RETRACTOR SYSTEM; RING CLAMP

Model Number	AL-0103
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 18 march 2024, seaspine was made aware of an intra-operative malfunction involving the alif retractor system.The case occurred on (b)(6) 2024.It was reported that several al-0103 ring clamps froze mid-case which made changing the blades difficult.This malfunction caused a surgical delay of approximately 45-60 minutes.The case was completed after the proper retraction was achieved.No patient injury was reported.On 17 april 2024 the al-0103 ring clamps were received for evaluation.The returned parts are as follow: (qty:1, p/n: al-0103, lot:1222) & (qty:5, p/n: al-0103, lot:0423).This report is 5 out of 5 for lot 0423.This event was originally reported under 3012120772-2024-00009.This report was filed to document the different lot numbers received.
Additional Manufacturer Narrative
The customer returned qty:1, p/n: al-0103, lot:1222 and qty:5, p/n: al-0103, lot:0423.The al-0103 ring clamps are currently being evaluated.The investigation is ongoing.No definitive root cause could be established at this time.No further details were provided by the reporter.The case was completed after the proper retraction was achieved.No patient injury was reported.Potential adverse effects: injury, trauma, infection and delayed procedure.
Additional Manufacturer Narrative
The (b)(6) ring clamps were evaluated and the results of the evaluation are as follow: · the evaluated (b)(6) ring clamps (qty:(b)(4), p/n: (b)(6), lot:1222) & (qty:(b)(4), p/n: (b)(6), lot:0423) were received in a seized condition.The clamps had minimal movement and were heavily damaged due to the removing tools.· the clamps were able to be set free(unseize) and functionality was restored with the application of lubricant.However, damaged was noted on the threads.· a lack of lubrication was noted as a root cause.No further details were provided by the reporter.The case was completed after the proper retraction was achieved.No patient injury was reported.Potential adverse effects: injury, trauma, infection and delayed procedure.
Event or Problem Description
On 18 march 2024, seaspine was made aware of an intra-operative malfunction involving the alif retractor system.The case occurred on (b)(6) 2024.It was reported that several al-0103 ring clamps froze mid-case which made changing the blades difficult.This malfunction caused a surgical delay of approximately 45-60 minutes.The case was completed after the proper retraction was achieved.No patient injury was reported.On 17 april 2024 the al-0103 ring clamps were received for evaluation.The returned parts are as follow: (qty:(b)(4), p/n: (b)(6), lot:1222) & (qty:(b)(4), p/n: (b)(6), lot:0423).This report is 5 out of 5 for lot 0423.This event was originally reported under 3012120772-2024-00009.This report was filed to document the different lot numbers received.On 30 may 2024 the evaluation was completed and as a result this supplemental report was submitted.

• Brand Name: ALIF RETRACTOR SYSTEM
• Common Device Name: RING CLAMP
• Manufacturer (Section D): TEDAN SURGICAL INNOVATIONS, INC; 12320 cardinal meadow drive; suite 150; sugar land TX 77478
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: robin quiusky ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 19326064
• Report Number: 3012120772-2024-00023
• Device Sequence Number: 2569757
• Product Code: FWZ
• UDI-Device Identifier: 00843059100945
• UDI-Public: 00843059100945
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: AL-0103
• Device Catalogue Number: AL-0103
• Device Lot Number: 0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown