MAUDE Adverse Event Report: LDR MEDICAL INTERBRIDGE LOCKING PLATE S; INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM

Catalog Number IB1002T

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the during the procedure the threads of the locking plate were stripped when the locking plate's set screw was being placed.The locking plate was removed and an alternate was used to complete the case.There was a delay greater than 30 minutes.No additional patient impacts were reported.

Event Description

It was reported the during the procedure the threads of the locking plate were stripped when the locking plate's set screw was being placed.The locking plate was removed and an alternate was used to complete the case.There was a delay greater than 30 minutes.No additional patient impacts were reported.

Manufacturer Narrative

Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces being applied during implantation.Complaint history there was one (1) other complaint for similar events related to the same part number in the 12 months leading up to the notification date through to the present.There were zero (0) other complaints related to this lot number in all time.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.If additional information becomes available that changes this report, a follow-up report will be submitted.

• Brand Name: INTERBRIDGE LOCKING PLATE S
• Type of Device: INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 9327652
• MDR Text Key: 166579007
• Report Number: 3004788213-2019-00321
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• PMA/PMN Number: K133363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: IB1002T
• Device Lot Number: 280771/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other