MAUDE Adverse Event Report: SYNTHES GMBH PEDIATRIC LCP HIP PLATE 5.0MM/130/5 HOLES; PLATE, FIXATION ,BONE

Model Number	02.108.341
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Additional product code: hwc jds.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the pediatric hip plate proximal locking screws pulled out.The patient had corrective osteotomy of femur surgery.Locking screws had been tightened with torque limiter but screws are pulled out and the patient is in the pain.The patient is required revision surgery.No further information is available.This complaint involves an unknown number of devices.This report is for one (1) pediatric lcp hip plate 5.0mm/130°/5 holes.This is report 4 of 4 for complaint (b)(4).

• Brand Name: PEDIATRIC LCP HIP PLATE 5.0MM/130/5 HOLES
• Common Device Name: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12673537
• Report Number: 8030965-2021-08860
• Device Sequence Number: 1206267
• Product Code: HRS
• UDI-Device Identifier: 10886982029959
• UDI-Public: (01)10886982029959
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K112085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.108.341
• Device Catalogue Number: 02.108.341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention