MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG DISTRACTION; DISTRACTOR

Model Number	51-557-20-71
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon activation, distractor footplate was observed to be bending on ct scan due to incomplete installation procedure.It was removed and replaced and new distractor performed as expected.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as device was lost in transit, therefore unavailable for device investigation.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.Based on the information provided the results conclude that the most likely root cause is user related.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: 9610905-2023-00017 and mdr: 9610905-2023-00018.
Additional Manufacturer Narrative
An initial investigation was performed on the basis of complaint statistics as the device was identified as lost in transit.The product was delivered and an investigation of the actual suspected device was successfully completed.The results of the investigation have identified no manufacturing issues, no design issues and/or corrective actions necessary at this time.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Additional information: lost in transit product received for investigation.Corrected data: g1 - contact company name.G1 - manufacturer name.H6 - component code (g).Type of investigation (b).Investigation conclusion (d).D9 - yes.

• Brand Name: DISTRACTION
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN SE & CO. KG; kilbinger strasse 10; muehlheim/donau, FL 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 16824401
• Report Number: 9610905-2023-00018
• Device Sequence Number: 6987122
• Product Code: MQN
• UDI-Device Identifier: 00888118105370
• UDI-Public: (01)00888118105370
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K161470
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 51-557-20-71
• Device Lot Number: 33498089
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 06/12/2025
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 10/06/2023; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male