MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; SCREW

Model Number SEE H10

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problem Impaired Healing (2378)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Mdr: 9610905-2021-00071.Possible parts and lots: 24-016-07-70 lot: 33333780, 33370819, 33388777, 24-016-07-71 lot: 33399515.

Event Description

It was reported that the screws pulled from the bone due to patient coughing and necessitated removal of the screws.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Multiple mdr reports were filed for this event.Mdr: 9610905-2021-00071.H4= 2021-02-01 | 2019-10-07 | 2020-07-30 | 2020-12-11.

• Brand Name: LEVEL ONE THORACIC
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 12309962
• MDR Text Key: 266159725
• Report Number: 9610905-2021-00073
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K153482
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other