MAUDE Adverse Event Report: AESCULAP AG PROSPACE XP IMPLANT 5° 7X8.5X26MM; IMPLANTS INTERBODY FUSION

Model Number	SO147P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a prospace xp implant 5° 7x8.5x26mm (part # so147p) was used during a procedure performed on (b)(6) 2021.According to the complainant, the xp cage was broken.Reportedly, one-third of the cage tip was damaged and remained in the patient's vertebral body.The implant was removed.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: we made a visual and microscopic investigation of the received implant especially of the fracture surfaces and the implant / insertion- instrument interface.The implant fragments seem to be complete, no larger pieces are missing the implant / instrument interface at the left side shows deformations and pressure points, while the right side has no deformations or pressure marks.These are clear signs of a one-sided high mechanical load (possibly levering during the insertion of the implant).The fractured surfaces themselves show no evidence of material defects such as foreign inclusions or blowholes.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Risk analysis showed probability 2(5) and severity according to product risk analysis (pra) 3(5); the current failure rate is within the risk analysis and therefore acceptable.Explanation and rationale: the deformations at the instrument connection interface and at the hold are sure signs that high forces were applied during implantation.This, combined with leverage effects, caused the implant to fracture.There is no evidence of a manufacturing problem in the manufacturing quality records.A material defect or a manufacturing error can be excluded.Conclusion/preventive measures: based upon investigation results, the root cause of the problem is most probably usage-related.Based upon investigation results, a capa is not necessary.
Event or Problem Description
Update: the procedure was performed at level l5-s1.The patient had spinal canal stenosis with narrowing between vertebral bodies.It was noted that using a 7mm shaver distractor alone was difficult, so a claw- shaped distractor was used to open and then lifted with 7mm.Cage was inserted after dissection and bone filling.At the time of inserting the cage, the image was confirmed and the image was driven in, and the marker position and the inserter position became an unnatural image from the middle.The damaged debris was collected and the tip of the inserter was confirmed to be damaged.The inserter itself was not damaged and the cage tip 1/3 remained in the patient's vertebral body.The doctor tried to remove it using a special remover, but it was difficult to remove it.Finally, the trailing edge of the vertebral body was scraped with a chisel and opened using a inge lamina spreaders.Then, it was possible to recover the tip of the cage by removing it again with a special remover.After that, the same size was installed in the open state with a inge lamina spreaders, and it was completed without any problem.

• Brand Name: PROSPACE XP IMPLANT 5° 7X8.5X26MM
• Common Device Name: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12888081
• Report Number: 9610612-2021-00744
• Device Sequence Number: 11853168
• Product Code: MAX
• UDI-Device Identifier: 04046964073717
• UDI-Public: 4046964073717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: SO147P
• Device Catalogue Number: SO147P
• Device Lot Number: 52486273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male