MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS PROSPACE TITANIUM PLIF IMPL.8° 7X7X22MM; IMPLANTS INTERBODY FUSION

Model Number FJ274T

Device Problem Crack (1135)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that when the surgeon was inserting the cage during the surgery that the cage was bent.The surgeon removed the cage by using another instrument to set it in proper position.The surgeon found that the crack of the cage while re-inserting could not be performed smoothly.The procedure was completed by using a new cage and there was no harm to the patient.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 5000 digital microscope.We made a microscopic inspection of the implant interface.Here we found one edge bent and one bent broken.The extract of the drawing shows the target state.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: without further knowledge about the circumstances we assume, that the implant was not correctly applied at the inserter and or handled with too much force.No capa is necessary.

• Brand Name: PROSPACE TITANIUM PLIF IMPL.8° 7X7X22MM
• Type of Device: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6377995
• MDR Text Key: 69103442
• Report Number: 9610612-2017-00063
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: FJ274T
• Device Catalogue Number: FJ274T
• Device Lot Number: 52053133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2017
• Device Age: 32 MO
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 02/02/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2017
• 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