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

Model Number	51-563-30-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
Patient had a cranial distractor implanted on (b)(6) 2017.The distractor broke sometime thereafter.A second surgery was completed to replace the broken device on (b)(6) 2017.Patient's mother reported that the patient played with the device frequently.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the distractor returned.Process evaluation was also completed on the lot number provided.The stereo microscope investigation revealed tensile cracks.Further investigation determined that there was no indication of material or manufacturing defects observed.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.The results of the investigation have concluded the root cause for the device breaking was due to strain on the device which caused mechanical stress.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: DISTRACTION, INTERNAL
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6705195
• Report Number: 9610905-2017-00059
• Device Sequence Number: 964524
• Product Code: MQN
• UDI-Device Identifier: 00888118082145
• UDI-Public: (01)00888118082145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017
• Report Date (Section F): 06/12/2017

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: Physician
• Device Model Number: 51-563-30-09
• Device Lot Number: 33026882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 YR