MAUDE Adverse Event Report: AESCULAP AG ENNOVATE OPEN LAT.OFFSET CONNECTOR 20MM; SPINE SURGERY

Model Number SY716TS

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual inspection: in the first step a visual inspection of all received components was made.The involved rods (sy439ts; sy440ts) were bent to the required shape during the operation but were not shortened or cut.Since all three (3) sy717ts have the same lot number, they are referred to with "a, b, c".The overall length of the individual sy171ts (a-c) was shortened from the original size of 52.11 mm to the following dimensions: sy717ts a = 31,97mm ; sy717ts b = 33,68 mm ; sy717ts c = 46,36 mm.In the next step, the width of the implant head was checked, and all measured values were within the specifications.Next, microscopic inspection of each component was made, especially the contact surfaces.Sy717ts-a shows a little wear at the lower edge of the body, the imprint on the flank runs over two thirds of the length and lies below the edge of the rod holder body, the off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body.Sy717ts-b shows little wear at both edges of the body, the anodized layer on the bottom of the body also has small, bare spots, which is a sign that the rod rested evenly on the bottom of the body, the imprint on the flank runs more than two thirds of the length in the middle and lies below the edge of the rod holder body, the off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body.Sy717ts-c shows practically no wear at the lower edge of the body, the imprint on the flank runs over the whole length but it lies directly on the edge of the rod holder body.The center depression on the locking screw in conjunction with the positions of the other impressions, this is a sign that the rod was not 100% correctly placed in the connector.Sy716ts shows clearly visible wear at both edges of the body, the imprint on the flank runs the entire length and lies below the edge of the rod holder body and shows clear signs of abrasion.The off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body, but it shows clearly signs of abrasion, too.On both rods (sy439ts; sy440ts, involved components) there are also traces of abrasion in one place.Batch 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.There are no similar complaints against the same lot numbers.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: the root cause for the problem could not be finally concluded.The pressure and chafing marks and the location of these features in some areas of the implants indicate that the positioning of the rods in relation to the connectors was not optimal in 100%.Since the implants themselves do not have any manufacturing-related defects and the documentation accompanying the production of the rods and connectors does not show any deviations, we can rule out a product-related cause for the complaint.Based upon the investigation results, a capa is not necessary.

Event Description

It was reported that there was an issue with the product sy716ts - ennovate open lat ffset connector 20mm.According to the complaint description, there was postoperative loosening noted after four (4) years.A revision was performed on (b)(6) 2024; dorsal revision and lengthening spondylodeses l2-ilium with replacement of connectors and strengthening of double-technique, and also side-to-side connection, and debridement no further data was provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch reports: 9610612-2024-00025 (aesculap ag reference no.(b)(4) - sy716ts).9610612-2024-00022 (aesculap ag reference no.(b)(4) - sy717ts).Involved components: aesculap ag reference no.(b)(4) - sy439ts/ ennovate curved rod 5.5x90mm.- lot 52729574.Aesculap ag reference no.(b)(4) - sy440ts/ ennovate curved rod 5.5x100mm - lot 52746257.

• Brand Name: ENNOVATE OPEN LAT.OFFSET CONNECTOR 20MM
• 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 grün ; po box 40; tuttlingen 78501
• MDR Report Key: 18791362
• MDR Text Key: 336396333
• Report Number: 9610612-2024-00025
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY716TS
• Device Catalogue Number: SY716TS
• Device Lot Number: 52661553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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
• Treatment: SY439TS - LOT 52729574; SY440TS - LOT 52746257
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 140 KG