MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK IMPLANT 5° 26X11.5X9MM; IMPLANTS INTERBODY FUSION

Model Number SJ909P

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No product at hand.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.There are no similar complaints with this error pattern from the whole product family "tspace peek" at hand.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: due to the circumstances we do not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure.The present complaint is the only complaint with this error pattern over the whole product family with a volume of sold units of (b)(4) pieces alone from the lot 52463321 we sold (b)(4) pieces without further complaints up till now.A material defect or a manufacturing error can be excluded.Without further knowledge about the circumstances, we assume a failure during the preparation of the intervertebral disc space.

Event Description

It was reported the tspace cage broke intraoperatively.The reporter indicated a patient with severe spondylolisthesis at l4-l5 and a narrow disc space anteriorly underwent a transforaminal interbody lumbar fusion (tlif) procedure.The surgeon planned to use tspace 9mm 5 degree device, force was applied while implanting the interbody fusion cage but due to the patient's spinal anatomical condition, the cage broke.The broken cage was still intact.There was no harm to the patient, however, no interbody fusion cage was used for the patient.Additional information has been requested, however, not yet received.

• Brand Name: TSPACE PEEK IMPLANT 5° 26X11.5X9MM
• Type of Device: 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8592733
• MDR Text Key: 144969131
• Report Number: 9610612-2019-00301
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: BX
• PMA/PMN Number: K071983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: SJ909P
• Device Catalogue Number: SJ909P
• Device Lot Number: 52463321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/25/2019
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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