MAUDE Adverse Event Report: AESCULAP AG PROSPACE XP IMPLANT 8° 9X8.5X22MM; SPINE SURGERY

Model Number SO129P

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with so129p - prospace xp implant 8° 9x8.5x22mm.According to the complaint description, the cage was in an abnormal position intraoperatively.This occurred during a monoportal posterior lumbar interbody fusion (plif) procedure.X-ray results confirmed that one was inserted laterally; attempts were made to remove and reinsert it, but the implant could not be grasped well.An additional medical intervention was required.Additional details have been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: h6 - codes updated.Investigation results: as of the date of this report the complaint product was not provided for investigation.The provided images / sketches are not sufficient for a final cause analysis.There is no further information available at this time.Investigation was based on review of device history records and historical data analysis.Device history review: the device quality and manufacturing history records 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.Currently there are no further complaints with this lot and error pattern at hand.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, section 803.3, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, additional medical intervention.Conclusion/preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

• Brand Name: PROSPACE XP IMPLANT 8° 9X8.5X22MM
• Type of Device: SPINE SURGERY
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15868705
• MDR Text Key: 304342738
• Report Number: 9610612-2022-00348
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO129P
• Device Catalogue Number: SO129P
• Device Lot Number: 52761057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention