MAUDE Adverse Event Report: ALPHATEC SPINE, INC. PSX INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	320-08102500
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an interbody cage collapsed postoperatively.A revision surgery was performed to remove the implant.
Additional Manufacturer Narrative
Neither the original surgery nor revision surgery date were provided.The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
H6: investigation findings:4248.Investigation conclusion: 61.H10.This interbody was placed and saw post-operative collapse which resulted in a revision cage necessary.Following explanation, the implant was sent here for evaluation.Below is a list of the findings that i saw when analyzing the interbody: the running torque of the implant (expansion and collapse directions) was measured with torque meter and values between 0.50-0.80 in-oz were recorded across the length of the expansion distance.Per the p/n 320-xxxxxx00 drawing as stated on flag note 2 (shown below) a minimum of 4.5 in-oz is required of an in-specification interbody.This specification is on the qir and is 100% inspected on all incoming interbodies.The engineering team investigated damage to the interbody, specifically the expansion mechanism.The drive screw anti-collapse tines are intact and seem to be in good condition.There is graft material present, but this is expected.The drop in torsional resistance likely occurred after the interbody was placed in the non-sterile set caddy and then implantation of the device.Because the interbody appears to be structurally sound, then it is most likely that a relaxation of the drive screw tines occurred during this timeframe.The only manner in which the engineering team was able to replicate the drop of torsional resistance is the repeated motion of fully expanding and collapsing the interbody multiple times.Therefore, it seems most likely that this failure mode occurred prior to the implantation of the cage and stems from the potential repeated testing/demo of the interbody prior to use.Labeling review: "preoperative management: the condition of all implants and instruments should be checked prior to use.Damaged and/or worn implants and instruments should not be used." "possible adverse effects: possible adverse effects include: initial or delayed loosening, bending, dislocation, and/or breakage of device components.".

• Brand Name: PSX INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16375962
• Report Number: 2027467-2023-00009
• Device Sequence Number: 15046762
• Product Code: MAX
• UDI-Device Identifier: 00190376396781
• UDI-Public: (01)00190376396781(10)SM147911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K211873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 320-08102500
• Device Catalogue Number: 320-08102500
• Device Lot Number: SM147911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown