MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 20 MM

Model Number	62-02323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by the company representative that after the distraction was completed successfully, the patient experienced infection at the posterior port where distractor was activated.Additional surgery was completed to assist with resolving of infection.No other information is known at this time.
Event or Problem Description
It was reported by the company representative that after the distraction was completed successfully, the patient experienced infection at the posterior port where distractor was activated.Additional surgery was completed to assist with resolving of infection.No other information is known at this time.
Additional Manufacturer Narrative
The reported event could not be confirmed.Due to the nature of the complaint, no visual, functional or dimensional inspections were performed.This report is based on received information only.For infection complaints, expanded investigations are performed to assure that neither the complained device nor all related manufacturing process steps have caused or contributed to the reported event.All results were documented within the ¿infection complaints - checklist investigator¿ (cmfqf 13-002).No discrepancies were found.To gain more information about the complained event the ¿infection complaints checklist customer¿ (cmfqf 13-003) was forwarded to the sales rep.It was assumed that the stryker device could be the reason for the infection because it was implanted near the open port that was infected.Infection is a known adverse event related to this procedure.In general, infections, foreign body reactions and inflammations following the insertion of implants are well known adverse events associated with these procedures.They are well documented in the instruction for use and have been considered in the risk evaluation of the relevant stryker product.This type of adverse event may rather be clinically related than implant related.Overall, the benefits of this product to the patient were found to outweigh the possible occurrence of inflammations.Therefore, inflammations at implant sites are considered a risk which is induced by the procedure but does not exceed the benefits involved.Furthermore, the reported event was discussed with the related r&d engineer.Because of the surgeon put a red rubber catheter over the distractor to help ensure port remains open to allow drainage, there might be the chance that the infection organism came through the open skin.Indications for a design, material or manufacturing related issue could not be found in the investigation.H3 other text : implanted.

• Brand Name: PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 20 MM
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 12380479
• Report Number: 0008010177-2021-00042
• Device Sequence Number: 3601853
• Product Code: MQN
• UDI-Device Identifier: 07613327291315
• UDI-Public: 07613327291315
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: 62-02323
• Device Catalogue Number: 62-02323
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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: Required Intervention