MAUDE Adverse Event Report: AESCULAP AG AND CO. KG PROSPACE XP IMPLANT 5 DEGREE 10X10.5X22MM ; SPINAL IMPLANT

Model Number SO420P

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Tantalum pins were not visible in x-ray.Primary surgery; (b)(6) 2015.Revision surgery: none.Involved component: none.Operation was delayed over 15 minutes.Summary: the surgeon used two prospace implants for this surgery.When he checked the x-ray image while inserted the second implant, tantalum pins were not visible in x-ray image.Due to this issue, he was not able to confirm the position of the implant.Therefore, he removed the second implant from the pt.After removal, the surgeon tried to see the implant using x-ray and the tantalum pins were not shown in the image.The first implant, which had no defect was from a different batch number.

Manufacturer Narrative

Mfg site eval: eval on-going.

Manufacturer Narrative

The following components were received for analysis: so420p, lot: 51987639, manufactured: 02/17/2014.The tantalum x-ray markers were not visible on x-ray.The surgeon assumed the markers were not inside the implant.The manufacturing documentation has been checked for all of the above listed lot numbers.There is no indication for a manufacturing error or material defect.The x-ray markers of this device were made from titanium.This batch of prospace was manufactured according to the specification that was valid at the time of manufacture.Since then, the prospace have been modified to comprise tantalum markers.

Manufacturer Narrative

Aesculap inc.Has initiated a recall of this material; 2916714-6/18/18-005r.

• Brand Name: PROSPACE XP IMPLANT 5 DEGREE 10X10.5X22MM
• Type of Device: SPINAL IMPLANT
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen DE 78532
• MDR Report Key: 4954182
• MDR Text Key: 17338339
• Report Number: 3005673311-2015-00078
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K132421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO420P
• Device Catalogue Number: SO420P
• Device Lot Number: 51987639
• Date Manufacturer Received: 06/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other