MAUDE Adverse Event Report: AESCULAP AG PROSPACE XP IMPLANT 0 10X10.5X26MM

Model Number SO440P

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).When the implant (so440p) was attached to the instrument for insertion, the implant loosened from the device.The insertion instrument was changed and again, the implant would not stay affixed.The surgery was completed successfully; however, there was a delay greater than 15 minutes.

Manufacturer Narrative

The following components were received for analysis: so440p lot: 52076117.Description of problem: the surgeon had difficulties holding the cage with the insertion instrument.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.We assume that the problem was a result of user error.Corrective / preventive action not required.

• Brand Name: PROSPACE XP IMPLANT 0 10X10.5X26MM
• Manufacturer (Section D): AESCULAP AG; tuttlingen DE ; GM
• Manufacturer (Section G): AESCULAP ; 3773 corporate pwky.; center valley PA 18034
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5084111
• MDR Text Key: 26127590
• Report Number: 3005673311-2015-00127
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO440P
• Device Catalogue Number: SO440P
• Device Lot Number: 52076117
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other